BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOVERMATT

    MDR report key: 7921762 · Received October 1, 2018

    Report

    Report Number
    7921762
    Event Type
    Malfunction
    Date Received
    October 1, 2018
    Date of Event
    August 31, 2018
    Report Date
    September 19, 2018
    Manufacturer
    D.T. DAVIS ENTERPRISES LTD.
    Product Code
    FRZ
    UDI-DI
    00816299010053
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    NURSE SAID PATIENT NEEDED TO BE ON A STRETCHER AND SHOULD BE SLID OVER TO THE STRETCHER. TRANSPORTERS ROLLED PATIENT FROM SIDE TO SIDE TO PLACE THE REUSABLE HOVERMATT UNDER PATIENT. THE STRETCHER WAS PLACED ALONGSIDE THE BED. TRANSPORTERS INFLATED THE HOVERMATT AND SLOWLY SLID THE PATIENT OVER IN THE DIRECTION OF THE STRETCHER. WHILE SLIDING THE HOVERMATT OVER ON TO THE STRETCHER IT SEEMED TO MEET SOME RESISTANCE IN THE SOUND OF IT'S INFLATION AND THEN GAIN IT BACK. THE PATIENT WAS IN THE MIDDLE OF THE STRETCHER. TRANSPORTERS AGREED HE WAS SET ON THE STRETCHER AND MOVED TO TURN OFF CANISTER AND DEFLATE THE HOVERMATT. SUDDENLY THE PATIENT AND HOVERMATT STARTED MOVING TOWARD THE EDGE OF THE BED AND THE TOP HALF OF THE MATT WITH PATIENT SLID TO THE GROUND. PATIENTS FEET REMAINED ON THE STRETCHER. HOVERMATT REMAINED INFLATED AND PATIENT DENIES STRIKING HEAD OR ANY INJURY. HOVERMATT REMOVED FROM SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765682 HOVERMATT DEVICE, PATIENT TRANSFER, POWERED FRZ D.T. DAVIS ENTERPRISES LTD. HM34HS 00816299010053

    Patients

    Seq Age Sex Outcome Treatment
    1