MAUDE Adverse Event Report: PHILIPS ELECTRONICS LTD. PHILIPS DREAM STATION BI-PAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problems Nonstandard Device (1420); Contamination /Decontamination Problem (2895)

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

Event Date 07/01/2021

Event Type  malfunction  

Event Description

I have a philips bi-pap machine and have met all their recall info.My dr says due to the severity of my problem.I should continue using it.However i have noticed over the last 3 months that the filters are getting darker and darker, i have photos that you should see.The actual filter itself had a residue on it which i scraped off and still have.I'm very concerned by this due to the recall.Looking forward to your response (b)(6).Fda safety report id# (b)(4).

• Brand Name: PHILIPS DREAM STATION BI-PAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS ELECTRONICS LTD.
• MDR Report Key: 12953521
• MDR Text Key: 281928583
• Report Number: MW5105857
• 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: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• 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: ATORVASTATIN ; FISH OIL ; VITAMINS B, C, D, E
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Race: White