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

Device Problem Fluid/Blood Leak (1250)

Patient Problem Sleep Dysfunction (2517)

Event Date 02/01/2022

Event Type  malfunction  

Event Description

The machine was leaking after i "wrote" it for a while.Never leaked before.I've used it for a long time but after losing weight didn't need it as much so i quit using it.I of course gained the weight back and again needed it.It was at this time that it started leaking.I ordered new hoses and masks and filters but that didn't help.I woke up in a pool of water.I need my machine.I'm back to falling asleep when working and driving.Fda safety report id # (b)(4).

• Brand Name: CPAP DEVICE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 13995801
• MDR Text Key: 288661369
• Report Number: MW5108734
• 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: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White