MAUDE Adverse Event Report: PHILIPS ELECTRONICS LTD DREAMSTATION BIPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Contacted philips and registered bipap device after finding black foam in water chamber on (b)(6) 2021 and still waiting for new device.Contacted hmsa to inquire about a new device since i have severe sleep apnea and they said because my machine is less than 5 years old they cannot issue a new machine.I am currently still using machine and would like to be helped please.Thank you.Fda safety report id # (b)(4).

• Brand Name: DREAMSTATION BIPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS ELECTRONICS LTD
• MDR Report Key: 12934209
• MDR Text Key: 281906469
• Report Number: MW5105809
• 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: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Sex: Male