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

Device Problem Fitting Problem (2183)

Patient Problem Insufficient Information (4580)

Event Date 02/14/2023

Event Type  malfunction  

Event Description

Got a replacement and called because of the modem does not fit in the machine they sent me.Have filed complaint for the philips respironics dreamstation machine.

• Brand Name: PHILIPS RESPIRONICS DREAMSTATION MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS RESP / RESPIRONICS INC.
• MDR Report Key: 16399438
• MDR Text Key: 309911867
• Report Number: MW5115034
• 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: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White