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

Model Number CAX501H12C

Device Problems Degraded (1153); Nonstandard Device (1420); Particulates (1451)

Patient Problem Aspiration/Inhalation (1725)

Event Date 07/05/2022

Event Type  malfunction  

Event Description

My philips dreamstation cpap is on the recall list.I registered my device in (b)(6) 2021 for the recall.At the time, my machine had none of the issues mentioned (black flecks in tubing etc), and i didn't use any ozone cleaner for my machine.My doctor advised i should continue using the machine.I was not overly concerned at that time and assumed that the recall - since it was due to a health issue - would be resolved in a timely manner.In (b)(6) 2022, when changing my filter, it was black.On further check, i noticed small black flecks in my tubing.I stopped using the device immediately, and on contacting my doctor, he agreed that i should no longer use the machine.There is currently no timeline available as to when i will receive my replacement cpap machine.When i called philips in fall 2021 to ask, i was told that they expected all machines to be replaced by the end of the calendar year (2021).When i called again today ((b)(6) 2022) i was told (again) that they expect all machines to be replaced by the end of the year (2022).I have no confidence in that timeline and am now very concerned for my risk of developing health issues related to untreated sleep apnea.Since philips knew of the issues starting in 2011, they should have been pro-active in preparing for a subsequent recall.Fda safety report id # (b)(4).

• Brand Name: PHILIPS RESPIRONICS DREAM STATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS INC.
• MDR Report Key: 15562780
• MDR Text Key: 301581893
• Report Number: MW5112488
• Device Sequence Number: 2
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/05/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CAX501H12C
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2022
• Patient Sequence Number: 1
• Treatment: LEVOTHYROXIN; OCCASIONALLY TYLENOL; PREGABALIN
• Patient Age: 61 YR
• Patient Sex: Female