BEUDAMED
    FDA Adverse Event Death Summary report: N

    DRIVE

    MDR report key: 12323931 · Received August 16, 2021

    Report

    Report Number
    2438477-2021-00036
    Event Type
    Death
    Date Received
    August 16, 2021
    Date of Event
    July 23, 2021
    Report Date
    August 16, 2021
    Manufacturer
    HANGZHOU DUNLI MEDICAL INSTRUMENTS CO.,LTD
    Product Code
    FNL
    UDI-DI
    00822383180328
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    DRIVE DEVILBISS HEALTHCARE IS HE INITIAL IMPORTER OF THE DEVICE WHICH IS A BED. THE DEVICE HAS NOT BEEN RETRIEVED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED WHEN ADDITIONAL INFORMATION IS RECEIVED. WHILE IN USE THE INCLINED HEADBOARD SUDDENLY CRASHED DOWN. THE SERVICE PROVIDER REPLACED THE BED AND NOTED THAT THE MOTOR WAS BROKEN. THE USER WAS TRAUMATIZED BY THE SUDDEN MOVEMENT. SHE DID NOT FALL OUT OF THE BED. HER SPOUSE STATED THAT IT REQUIRED TWO DAYS OF HOURLY MEDICATION TO CALM HER DOWN. THE DEATH IS NOT ASCRIBED TO THE INCIDENT AS END-USER WAS ALREADY IN HOSPICE CARE FOR HUNTINGTON'S DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1222274 DRIVE BED FNL HANGZHOU DUNLI MEDICAL INSTRUMENTS CO.,LTD 15033 00822383180328

    Patients

    Seq Age Sex Outcome Treatment
    1 Death