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

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/15/2022

Event Type  malfunction  

Event Description

I am a lawyer.I represent (b)(6).Here is his complaint.A few years back i got a philips.On several occasions i would take the cpap to your office on (b)(6), drop it off so that filters could be installed, new parts gathered, etc., then i would pick it up later that day or the next.This worked fine for a considerable spell.Yesterday, however, when i attempted to drop off my resmed which i rented for a year when the philips proved to have a dangerous defect, i was told in no uncertain terms that your office did not take cpap machines in because "they are too busy." ultimately one of your employees came out to my vehicle and showed me how to install the filter, and gave me the new parts that i was entitled to get.Today i took my philips unit to the (b)(6) office and requested a filter and whatever else i was entitled to.I was advised that i would have to pay for this out of my pocket because i had picked up the items yesterday.I explained that this was the replacement unit for the defective cpap machine, and had nothing to do with the unit that i left yesterday - this explanation was to no avail.I advised your employee that this didn't make any sense and was told that i would need to take it up with my insurance company.It seems to me that it would be appropriate for your employees to take it up with the insurance company.This is ridiculous.I have been advised of similar complaints by friends of mine who have your cpaps.I am also advised that many people have registered complaints because of poor service.This won't do - so i have retained a lawyer, and "ere long" i am sure you will be hearing from him regarding a potential class action.Fda safety report id# (b)(4).

• Brand Name: CPAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC.
• MDR Report Key: 15003828
• MDR Text Key: 295954939
• Report Number: MW5110840
• 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: Attorney
• Type of Report: Initial
• Report Date: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/12/2022
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Male