BEUDAMED
    FDA Adverse Event Death Summary report: N

    DRIVE

    MDR report key: 11766908 · Received May 3, 2021

    Report

    Report Number
    2438477-2021-00017
    Event Type
    Death
    Date Received
    May 3, 2021
    Date of Event
    April 2, 2021
    Report Date
    May 3, 2021
    Manufacturer
    HANGZHOU DUNLI MEDICAL INSTRUMENTS CO.,LTD
    Product Code
    FNL
    UDI-DI
    00822383260556
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    DRIVE (B)(6) HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A BED. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE DEVICE WAS INVOLVED IN A FIRE. THE FIRE MARSHALL HAS NOTED THE ROOT CAUSE OF THE FIRE WAS IMPROPERLY DISCARDED SMOKING MATERIALS. THE FIRE IS SUSPECTED TO HAVE ORIGINATED AT THE BED. THE BED DID NOT CAUSE THE FIRE AS PER THE FIRE MARSHAL. ROOT CAUSE WAS IMPROPERLY DISCARDED SMOKING MATERIALS. AT LEAST 10 CIGARETTE BUTTS WERE FOUND IN THE BEDROOM. THE END USER WAS ESSENTIALLY BED BOUND. THE ROOM WAS FILLED WITH COMBUSTIBLE ITEMS. THE END USER WAS SMOKING IN BED, AND USING O2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662469 DRIVE BED FNL HANGZHOU DUNLI MEDICAL INSTRUMENTS CO.,LTD 15548 00822383260556

    Patients

    Seq Age Sex Outcome Treatment
    1 Death