BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANCE DELUXE ALTERNATING PRESSURE PUMP AND PAD

    MDR report key: 6336139 · Received February 16, 2017

    Report

    Report Number
    1056127-2017-00003
    Event Type
    Death
    Date Received
    February 16, 2017
    Date of Event
    February 6, 2017
    Report Date
    February 14, 2017
    Manufacturer
    APEX MEDICAL (KUNSHAN) CORP.
    Product Code
    FNM
    UDI-DI
    00754756390013
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT'S SPOUSE FOUND HIM HANGING OVER THE SIDE OF BED, HEAD FIRST, AND WEDGED BETWEEN HOSPITAL BED AND WALL OF HOME. POLICE PRONOUNCED HIM DEAD AT SCENE. HOSPICE SERVICE FILED MEDWATCH REPORT ON ALL EQUIPMENT PRESENT AT THE SCENE. REVIEW OF SCENE PHOTOGRAPHS SHOW AN APP MATRESS SECURELY PLACED UNDER A CONTOUR SHEET; THE SHEET AND PAD REMAINED PROPERLY IN PLACE ON BED. THE APP SYSTEM APPEARS NON-CONTRIBUTORY IN PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118199 ENDURANCE DELUXE ALTERNATING PRESSURE PUMP AND PAD APP FNM APEX MEDICAL (KUNSHAN) CORP. 9C526002 00754756390013

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death HOSPITAL BED AND BED RAILS