BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REM STAR CPAP MACHINE

    MDR report key: 12202355 · Received July 20, 2021

    Report

    Report Number
    MW5102634
    Event Type
    Malfunction
    Date Received
    July 20, 2021
    Report Date
    July 16, 2021
    Manufacturer
    PHILLIPS RESPIRONICS, INC.
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RECEIVED INFORMATION ABOUT A RECALL ON THE SERIAL NUMBER OF THE CPAP DEVICE. WAS ADVISED NOT TO CONTINUE USE OF THIS DEVICE BY PHILLIPS RESPIRONICS. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093578 REM STAR CPAP MACHINE VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILLIPS RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR