BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPAP MACHINE

    MDR report key: 13618995 · Received February 25, 2022

    Report

    Report Number
    MW5107749
    Event Type
    Injury
    Date Received
    February 25, 2022
    Date of Event
    June 1, 2021
    Report Date
    February 16, 2022
    Manufacturer
    PHILIPS/RESPIRONICS, INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    RECALL. ON (B)(6) 2021 I CONTACTED PHILIPS RESPIRONICS TO PLACE MY HUSBAND'S NAME ON THEIR LIST TO HAVE A REPLACEMENT OR A REPAIR KIT SENT TO REPAIR THE CPAP MACHINE. I EXPLAINED TO THEM THAT MY HUSBAND HAS LUNG CANCER AND HE CANNOT USE THE DEFECTIVE MACHINE ANY LONGER. I HAVE CALLED THEM AND NATIONWIDE SEVERAL TIMES ASKING WHEN THIS WILL BE COMPLETED. MY HUSBAND IS DYING AND THEY STILL IGNORE ME. WE HAVE A MACHINE THAT HE CANNOT USE. IT WAS RECALLED BECAUSE IT WAS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298099 CPAP MACHINE VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS/RESPIRONICS, INC. DSX400H11C

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Other HIS MEDICATIONS HAVE NOTHING TO DO WITH THE DEFECTI VE MACHINE.