Incident: Philips Respironics Sleep Device Recall Due to Faulty Components

Published Date: 2021-08-17

Postmortem Analysis
Timeline 1. The software failure incident involving the Philips Respironics machines happened in April 2021 [117465].
System 1. Philips Respironics BiPAP, CPAP, and ventilator machines manufactured before April 26 [117465]
Responsible Organization 1. Philips Respironics machines were responsible for causing the software failure incident as they were recalled due to potential health risks from faulty components [117465]. 2. The Food and Drug Administration (FDA) played a role in addressing the software failure incident by warning of potential health risks and overseeing the repair-and-replacement program for the flawed components [117465].
Impacted Organization 1. Patients with obstructive sleep apnea, breathing problems, and respiratory emergencies [117465] 2. Doctors and medical professionals who rely on these devices for patient care [117465] 3. Medical equipment suppliers and manufacturers [117465]
Software Causes unknown
Non-software Causes 1. Faulty components in the Philips Respironics machines, specifically the polyester-based polyurethane foam that degraded and could lead to health risks such as chemical exposure and ingestion of black debris [117465].
Impacts 1. Millions of people in the United States, along with their doctors, have been scrambling to find alternatives for those with common sleep disorders, breathing problems, and respiratory emergencies due to the recall of faulty Philips Respironics machines [117465]. 2. There are shortages and backlogged orders for replacement devices, created by delays in the replacements and the use of similar devices in emergency rooms and intensive-care units during the coronavirus pandemic [117465]. 3. Patients affected by the recall were placed on waiting lists by medical suppliers, and several weeks later, they still did not know when to expect their replacement devices [117465]. 4. Mayo Clinic contacted more than 4,500 patients who might have been affected by the recall, removed the devices from its hospitals and sleep clinics, and expressed concerns about the increasing number of medical device recalls [117465]. 5. The recall has led to a demand spike for alternative devices, with ResMed experiencing increased demand and prioritizing manufacturing devices for patients with immediate ventilator needs, including Covid patients [117465]. 6. The recall has exacerbated the existing supply-chain interruptions for CPAP machines, with shortages of materials like resins and computer chip modules, leading to a crisis situation in the supply of these devices [117465]. 7. Patients like Amy Sloane had to stop using their recalled devices immediately upon learning about the potential health risks, and some resorted to using devices from other manufacturers [117465].
Preventions 1. Implementing rigorous quality control measures during the manufacturing process to detect and prevent faulty components [117465]. 2. Conducting thorough testing and validation of the devices before releasing them to the market to identify any potential risks or defects [117465]. 3. Ensuring effective communication channels with customers to promptly notify them of any recalls or safety concerns related to the software or devices [117465]. 4. Providing clear guidance and instructions to users on how to address the issue, including steps to take in case of a recall or potential risk [117465]. 5. Regularly monitoring and evaluating the performance and safety of the software and devices post-market release to quickly identify any emerging issues or failures [117465].
Fixes 1. The software failure incident involving the Philips Respironics machines could be fixed by submitting a repair-and-replacement program for the faulty components to the Food and Drug Administration (FDA) [117465]. 2. Philips must conduct extensive testing on the repair and replacement devices, and the FDA will review the data before authorizing the plan [117465]. 3. Manufacturers and regulators, like the FDA, should learn from this mistake to prevent similar incidents in the future [117465].
References 1. Food and Drug Administration (FDA) [117465] 2. Royal Philips [117465] 3. Mayo Clinic [117465] 4. American Hospital Association [117465] 5. ResMed [117465] 6. American Association for Homecare [117465] 7. Silver Golub & Teitell [117465]

Software Taxonomy of Faults

Category Option Rationale
Recurring one_organization (a) The software failure incident related to the Philips Respironics machines is specific to Philips. The article mentions that Philips Respironics machines were recalled due to potential health risks from faulty components, specifically the polyester-based polyurethane foam that can degrade and result in users breathing in chemicals or swallowing black debris [117465]. (b) The article does not provide information about similar incidents happening at other organizations or with their products and services.
Phase (Design/Operation) design, operation (a) The software failure incident related to the design phase can be seen in the article where it mentions that Philips Respironics machines were recalled due to potential health risks from faulty components. The issue stemmed from the polyester-based polyurethane foam used in the machines, which could degrade and result in users breathing in chemicals or swallowing black debris [117465]. (b) The software failure incident related to the operation phase is evident in the article where it discusses how users like Amy Sloane had concerns about the safety of their DreamStation BiPAP Auto SV machine after learning about the recall. Amy Sloane stopped using her device immediately upon her physician's advice and was able to switch to an auto-adjusting CPAP machine by another manufacturer [117465].
Boundary (Internal/External) within_system, outside_system (a) within_system: The software failure incident related to the Philips Respironics machines was primarily caused by faulty components within the system. The article mentions that the potential health risks stemmed from a specific component, the polyester-based polyurethane foam, used in the machines [117465]. This foam could degrade over time, leading to users breathing in chemicals or swallowing/inhaling black debris, which posed serious health risks including toxic and carcinogenic effects on organs [117465]. (b) outside_system: The software failure incident also had external factors contributing to the failure. The shortage and backlogged orders for replacement devices were exacerbated by delays in replacements and the increased use of similar devices in emergency rooms and intensive-care units during the COVID-19 pandemic [117465]. Additionally, the demand for these devices increased due to the surge in COVID-19 cases, further straining the supply chain and availability of the necessary devices [117465].
Nature (Human/Non-human) non-human_actions, human_actions (a) The software failure incident in this case was primarily due to non-human actions, specifically faulty components in the Philips Respironics machines that deliver pressurized air through a mask. The potential harm stemmed from the degradation of polyester-based polyurethane foam in the machines, leading to risks of chemical exposure and ingestion of black debris [117465]. (b) Human actions also played a role in this software failure incident. For example, the company, Philips, had to submit a repair-and-replacement program for the flawed components to the Food and Drug Administration (F.D.A.) [117465]. Additionally, there were concerns raised about the lack of clear communication and guidance from Philips to affected customers, leading to uncertainty and confusion among doctors and patients [117465].
Dimension (Hardware/Software) hardware (a) The software failure incident occurring due to hardware: - The Philips Respironics machines were recalled due to potential health risks from faulty components, specifically the polyester-based polyurethane foam that can degrade and result in users breathing in chemicals or swallowing/inhaling black debris [117465]. - The faulty hardware components in the machines posed risks such as asthma, skin and respiratory-tract irritation, and potential toxic and carcinogenic effects on organs like the kidneys and liver [117465]. (b) The software failure incident occurring due to software: - The article does not mention any software-related contributing factors that originated in software for the failure incident.
Objective (Malicious/Non-malicious) non-malicious (a) The software failure incident related to the Philips Respironics machines was non-malicious. The failure was due to faulty components, specifically the polyester-based polyurethane foam used in the machines, which degraded over time and posed health risks to users [117465]. The recall was initiated by Philips due to potential health risks, including exposure to harmful chemicals and black debris, which could lead to serious health consequences [117465]. (b) There is no indication in the articles that the software failure incident was malicious. The failure was attributed to faulty components in the machines, rather than any intentional actions to harm the system [117465].
Intent (Poor/Accidental Decisions) unknown The articles do not provide information specifically related to a software failure incident caused by poor decisions or accidental decisions.
Capability (Incompetence/Accidental) accidental (a) The software failure incident related to the Philips Respironics machines was not due to development incompetence but rather due to faulty components in the machines. The issue stemmed from the degradation of polyester-based polyurethane foam used in the devices, leading to potential health risks for users [117465]. (b) The software failure incident with the Philips Respironics machines was accidental, as it was caused by faulty components in the machines that degraded over time, resulting in potential health risks for users. The degradation of the polyester-based polyurethane foam used in the devices was not intentional but rather an unforeseen issue that led to the recall of the affected machines [117465].
Duration temporary The software failure incident related to the Philips Respironics machines was temporary. The failure was due to faulty components in the machines, specifically the polyester-based polyurethane foam that could degrade and result in users breathing in chemicals or swallowing black debris [117465]. This issue led to a recall of the affected machines and the need for repair and replacement programs to address the faulty components. The incident caused shortages and backlogged orders, impacting millions of users in the United States who rely on these devices for sleep apnea and other respiratory conditions. The company was working on producing repair kits and replacement devices in large quantities but had not yet cleared them for shipping, indicating a temporary disruption in the availability of functioning devices [117465].
Behaviour crash (a) crash: The software failure incident in the articles can be categorized as a crash. The Philips Respironics machines were recalled due to potential health risks from faulty components, specifically the polyester-based polyurethane foam that could degrade and result in users breathing in chemicals or swallowing/inhaling black debris. This issue led to the recall of millions of devices, creating shortages and backlogged orders for replacements, ultimately causing the system to fail in delivering pressurized air through the mask as intended [117465].

IoT System Layer

Layer Option Rationale
Perception None None
Communication None None
Application None None

Other Details

Category Option Rationale
Consequence harm, theoretical_consequence (a) death: The software failure incident related to the Philips Respironics machines resulted in potential health risks that could be "life-threatening, cause permanent impairment and require medical intervention" [117465]. The potential harm included risks of particulate and chemical exposure that could lead to serious health effects such as toxic and carcinogenic effects on organs like the kidneys and liver. While the article does not directly mention any deaths resulting from the software failure incident, the severity of the potential health risks indicates a possibility of fatal outcomes for affected individuals.
Domain health The software failure incident discussed in the articles is related to the **health** industry. The incident involves the recall of Philips Respironics machines used for treating sleep disorders and respiratory emergencies, impacting millions of users in the United States [Article 117465]. The faulty components in these machines posed potential health risks, including exposure to harmful chemicals and carcinogenic effects, leading to the need for replacements and causing shortages in the supply of critical devices during the COVID-19 pandemic. The incident has raised concerns among doctors and patients about the safety and availability of essential medical devices, highlighting the significant impact on the healthcare sector.

Sources

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