BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS CPAP DEVICE

    MDR report key: 21883559 · Received April 22, 2025

    Report

    Report Number
    2518422-2025-104460
    Event Type
    Malfunction
    Date Received
    April 22, 2025
    Date of Event
    April 1, 2025
    Report Date
    April 22, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION THAT THE CUSTOMERS DEVICE HAS A BURNING SMELL AND SUDDENLY STOPPED WORKING. IT WON'T TURN ON AT ALL. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911440 PHILIPS CPAP DEVICE VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZB RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown