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

Device Problem Fitting Problem (2183)

Patient Problem Insufficient Information (4580)

Event Date 01/17/2023

Event Type  malfunction  

Event Description

Philips recalled my cpap device and sent a replacement device with instructions to remove the modem from the old device and place it in the new device.I have two issues with this: 1.The old device modem will not fit into the new device.Philips asked me to modify the device by removing the door rather than sending me a modem designed to fit into the device.I have a visual impairment.I am not comfortable modifying the device nor do i believe that is my responsibility since philips made the defective device.2.If the old device was contaminated with particles that could cause cancer, wouldn't transferring the modem into the new device cause cross-contamination? i would appreciate an investigation and would be grateful if you would order philips to send me a replacement unit that works without me having to modify it (which i believe is illegal).

• Brand Name: DREAM STATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS INC.
• MDR Report Key: 16215361
• MDR Text Key: 307981923
• Report Number: MW5114402
• Device Sequence Number: 2
• 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
• Type of Report: Initial
• Report Date: 01/17/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 2 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White