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

Device Problems Nonstandard Device (1420); Device Emits Odor (1425); Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Date 03/16/2023

Event Type  malfunction  

Event Description

I have not been able to use my cpap machine for over a year due to a recall.Philips finally sent me a machine, but it was an old refurbished unit with more time on it than my original recalled unit.I was promised a new dreamstation auto adjusting machine and instead got this old used dreamstation 1.It is noisy and smells like cigarettes.Reference report mw5115961.

• Brand Name: DREAMSTATION CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 16617805
• MDR Text Key: 312062451
• Report Number: MW5115960
• 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: 03/22/2023

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2023
• Patient Sequence Number: 1
• Treatment: MELATONIN; ZOLOFT
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 163 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White