MAUDE Adverse Event Report: PHILIPS/RESPIRONICS, INC PHILIPS RESPIRONICS DREAMSTATION BI-PAP-AUTOBIPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX700S11F

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 01/19/2023

Event Type  Injury  

Event Description

I was sent a replacement bi-bap phillis device to replace the prior one that made me ill, the new device is worse.This is the second time my device has failed and caused me medical issues.Reference report mw5116533.

• Brand Name: PHILIPS RESPIRONICS DREAMSTATION BI-PAP-AUTOBIPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC
• MDR Report Key: 16726031
• MDR Text Key: 313329758
• Report Number: MW5116532
• 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: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX700S11F
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: INSULIN, METFORMIN.
• Patient Outcome(s): Hospitalization; Disability; Life Threatening; Other; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White