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

Device Problems Product Quality Problem (1506); Patient-Device Incompatibility (2682)

Patient Problem Insufficient Information (4580)

Event Date 07/14/2021

Event Type  Injury  

Event Description

Need cpap machine to live; used a life threatening cancer causing cpap machine.Fda safety report id # (b)(4).

• Brand Name: PHILIPS DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS INC.
• MDR Report Key: 12210960
• MDR Text Key: 263252445
• Report Number: MW5102718
• Device Sequence Number: 1
• Product Code: BZD
• 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: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 118