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

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 07/28/2021

Event Type  Injury  

Event Description

I have been contacting philips with the cpap recall issue.While philips keeps telling me to contact (b)(4) with my prescription information, their system hangs up stating it has the number to call back within 48 working hours.I have yet to receive a call.I waited 26 minutes again today and the representative who said his id was 192 stated the p serial numbers cannot be filed.Again i called philips who stated they are aware of this and keep trying.How can they represent they are working on this, providing customers actions to take that they cannot follow.My filing number with philips for your reference is (b)(4).Please push philips to fix this as they have not albeit they are aware of this.Fda safety report id# (b)(4).

• Brand Name: PHILIPS CPAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC.
• MDR Report Key: 15925034
• MDR Text Key: 304974896
• Report Number: MW5113639
• 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
• Type of Report: Initial
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: METOPROLOL 25MG
• Patient Outcome(s): Life Threatening
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White