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

Model Number DSX500S11F

Device Problems Contamination (1120); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 03/23/2022

Event Type  malfunction  

Event Description

This is in regards to the philips cpap recall.I received a refurbished device that had shipped loose in a box, was not even wrapped in plastic, there was nothing obvious about the machine that signified it had been refurbished.Upon inspection the machine had dirty used filters still installed in it.Upon receipt of the device and discovering how dirty it was, i contacted philips, their representative (b)(4) assured me that this mistake couldn't have been possible with how strict their refurbishment program was.I emailed him pictures and he started a ticket (b)(4).A few days later i emailed him again and he stated my order had been processed but hadn't yet shipped for what i'm assuming is a new device (hopefully not another refurbished one as i don't think i could use it knowing what they previously sent).He also stated he sent the photos to his tier one team.I hadn't heard anything and attempted to contact him again through email on (b)(6) 2022 and again on (b)(6) 2022 and have yet to receive a response.I attempted to contact them by phone and was continually passed around from person to person, was disconnected about 4 times then was told they don't deal with that and would need to contact a different department.At this point i haven't tried again and see no reason why my email can not be responded to.It's been over 2 months since contacting them initially and have still not had a resolution to my case.I will include the pictures and can forward emails if needed.Fda safety report id# (b)(4).

• Brand Name: CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 14430354
• MDR Text Key: 292050868
• Report Number: MW5109769
• 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: 05/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DSX500S11F
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 9 DA
• Patient Sex: Male
• Patient Weight: 127 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White