BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOVERMATT

    MDR report key: 11655235 · Received April 12, 2021

    Report

    Report Number
    MW5100711
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Date of Event
    February 13, 2021
    Report Date
    April 8, 2021
    Manufacturer
    HOVERTECH INTERNATIONAL / D. T. DAVIS ENTERPRISES LTD.
    Product Code
    FRZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT'S UPPER BODY SLID OFF OF THE OPERATING ROOM TABLE. PT'S LOWER BODY WAS GUIDED OFF OF THE OPERATING ROOM TABLE BY SURGEON AND SURGICAL RESIDENTS. PT'S WOUND WAS PROTECTED BY SURGEON AND DRESSED IMMEDIATELY (STERILELY). PT LANDED ON RIGHT SHOULDER AND DID NOT LOSE CONSCIOUSNESS. PRIOR TO THE PT'S FALL, THE PT WAS POSITIONED ON THE OPERATING ROOM TABLE WITH THE TABLE TILTED TO THE RIGHT, RIGHT SIDE DOWN. PT WAS ALSO ON A HOVERMATT. SAFETY STRAPS WERE INTACT AROUND PT'S THIGHS AND ARMS BILATERALLY. BED WHEELS LOCKED. PT HAD BEEN RESTLESS ON AND OFF THROUGHOUT CASE, INTERVENTION WAS TAKEN. PT DID NOT APPEAR RESTLESS AT THE TIME OF THE FALL. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551569 HOVERMATT DEVICE, PATIENT TRANSFER, POWERED FRZ HOVERTECH INTERNATIONAL / D. T. DAVIS ENTERPRISES LTD. HM34SPU UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR