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

Device Problems Loose or Intermittent Connection (1371); Scratched Material (3020)

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

Event Date 10/10/2022

Event Type  malfunction  

Event Description

Philips recall of cpap machine.Philips sent me a replacement cpap device and it was marked as recertified device.However, on further inspection the device has a loose on/off switch and several scratches on the information screen.This device is unacceptable.I contacted philips to report this problem and asked to be placed back on the waiting list.I also asked for a new machine and not someone else's junk.I think this is a reasonable request as my device is in like new condition.Not sure where to go from here and i have not heard back from philips.Fda safety report id# (b)(4).

• Brand Name: DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS INC.
• MDR Report Key: 15595206
• MDR Text Key: 301746667
• Report Number: MW5112568
• 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: 10/10/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• 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: BABY ASPIRIN
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 122 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White