MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. TRILOGY 100 VENTILATOR; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problems Nonstandard Device (1420); Defective Device (2588)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Type  Death  

Event Description

On (b)(6) 2021 my wife of 62 years died in her sleep with her face mask on while using the philips trilogy 100 ventilator.She was a great wife, a great mother to our 3 children, a great grandmother to our 10 grandchildren, and my life is simply not the same without her.The doctor that signed the death certificate indicated that the cause of death was ¿congestive heart failure¿ but no autopsy was performed and he never even examined her body.I simply know that this defective device caused her death.(note that shortly before her death my wife complained about her unit being very dirty when cleaning it - we both now know that this was not dirt- it was the foam that was breaking down that she was seeing! i am not a litigious person and will not be bringing any litigation in connection with this material i am looking for is to see philips adequately punished for their outrageous conduct.Let me touch on a few things: your own reports- are shocking and indicate that philips knew of the detrimental effects of the degrading pe-pur foam for many years before they took any action.They continued to sell this ventilator without taking any corrective action or warning to either new or existing customers.Outrageous to say the least.The bottom line here is that when a company knows something is wrong with their product and sits on that data, especially when it involves their customer¿s health, that is more than ¿bad faith¿ and outrageous, that is malicious.Quality system regulations- a few brief comments: 820.72 inspection.Measuring etc.- equipment is required to be routinely calibrated, inspected, checked and maintained- either not done or hidden by management; 820.100 corrective and preventive action- ¿(3) identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems¿.They did nothing until you required the recall.Overall- philips is/was not in compliance with many, many of your comprehensive quality regulations which are designed to protect the public.I have read every piece of data i can find (tons) on this recall and while it is clear that you are aggressively addressing the recall (thank you) i question why i have seen no punishment for their outrageous and deficient unaddressed prior knowledge of this problem.(fines, license suspension, etc.) why?.

• Brand Name: TRILOGY 100 VENTILATOR
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 17239899
• MDR Text Key: 318283115
• Report Number: MW5119022
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death