BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOVERMATT LATERAL PATIENT TRANSFER DEVICE

    MDR report key: 2595352 · Received May 29, 2012

    Report

    Report Number
    2531468-2012-00001
    Event Type
    Other
    Date Received
    May 29, 2012
    Date of Event
    April 25, 2012
    Report Date
    May 29, 2012
    Manufacturer
    D.T. DAVIS ENTERPRISES LTD. T/A HOVERTECH INTERNATIONAL
    Product Code
    FRZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE HM34DC MINI HOVERMATT WAS RETURNED TO HOVERTECH ON 05/23/2012. AN INVESTIGATION WAS PERFORMED. WHEN TESTED IT WAS NOTED THAT THE 4 OF THE 6 STRINGERS WERE NO LONGER CONNECTING THE TOP OF THE MATT TO THE BOTTOM. THE INTERNAL STRUCTURE OF THE MATTRESS HAD FAILED CAUSING UNEVEN AND EXAGGERATED INFLATION OF THE PRODUCT. THE HOVERMATT WAS DISCOLORED AND THE AIR INLETS WERE TACKY. THESE CONDITIONS ARE NORMALLY ATTRIBUTED TO OVER PROCESSING OF THE MATTRESS, I.E. BEING LAUNDERED AT TOO HIGH A TEMPERATURE. AFTER TALKING TO (B)(6) AT THE FACILITY, SHE STATED THAT THE HOVERMATT IS NEVER MACHINE LAUNDERED. IT IS USUALLY WIPED CLEAN USING PERCEPT IN BETWEEN CASES. IF EXTREMELY SOILED THE MATTRESS IS HAND WASHED AND HUNG TO DRY. THE HOVERMATT WAS NEVER SENT TO LAUNDRY. HOVERTECH INTERNATIONAL QUALITY RECORDS WERE REVIEWED TO ASSURE THAT THIS WAS NOT A TRENDED DEFECT OR THE APPARENT RESULT OF A DESIGN DEFICIENCY. THERE ARE NO RECORDED LIKE FAILURES FOR THIS MODEL NUMBER PRODUCT.

    Description of Event or Problem · 1

    "THE MATT'S HEAT SEALS IN THE MIDDLE OF THE MATTRESS GAVE WAY AND THE MATT BALLOONED UP SO BIG AND ROUND THAT THE PT JUST ABOUT TIPPED OFF THE BED. THE PT WAS SAVED BY A STRONG NURSE WHO IS NOW LIMPING AROUND. THE SERIAL NUMBER OF THE MATT IS (B)(4)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOVERMATT LATERAL PATIENT TRANSFER DEVICE DEVICE, PATIENT TRANSFER, POWERED FRZ D.T. DAVIS ENTERPRISES LTD. T/A HOVERTECH INTERNATIONAL HM34HS MNI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR