MAUDE Adverse Event Report: DEVILBISS HEALTHCARE LLC. INTELLIPAP AUTOADJUST DV54D CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DV54D

Device Problems Degraded (1153); Material Fragmentation (1261); Nonstandard Device (1420); Particulates (1451)

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

Event Type  Injury  

Event Description

I am a cpap user.I have bought a devilbiss dv54d online from the us.I am a malaysian resident.Due to the philips recall on the foam issues, i have opened my cpap machine up and to my horror, the foam for the devilbiss have degraded and the foam particles and shedding is all over the fan motor and the chamber.I have no related symptoms but worry of the long terms risk for breathing in this foam material.No test performed.Only opened up and performed visual inspection of the sound abatement foam.

Event Description

Additional information received from reporter on june 27th 2023 for report number mw5118808.

• Brand Name: INTELLIPAP AUTOADJUST DV54D CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): DEVILBISS HEALTHCARE LLC.
• MDR Report Key: 17201482
• MDR Text Key: 317919793
• Report Number: MW5118808
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 06/27/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: DV54D
• Device Catalogue Number: DV54D
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/23/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/27/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian