BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOVERMATT LATERAL PATIENT TRANSFER DEVICE

    MDR report key: 2781990 · Received September 18, 2012

    Report

    Report Number
    2531468-2012-00002
    Event Type
    Injury
    Date Received
    September 18, 2012
    Date of Event
    April 26, 2012
    Report Date
    September 17, 2012
    Manufacturer
    D.T. DAVIS ENTERPRISES LTD. T/A HOVERTECH INTERNATIONAL
    Product Code
    FRZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS STATED IN THE REPORT FROM (B)(6): "AFTER THE INITIAL INVESTIGATION IT APPEARS THAT EITHER PROPER PT TRANSFER PROTOCOLS WHICH REQUIRE HOSPITAL BED BRAKES TO BE APPLIED BEFORE A TRANSFER COMMENCES WERE NOT ADHERED TO, OR THAT THE BRAKES ON THE BED WERE FAULTY." IT ALSO STATES IN THE HOVERMATT INSTRUCTIONS FOR USE; "ENSURE THE TRANSFER SURFACES ARE AS CLOSE AS POSSIBLE, AND BRAKE THE WHEELS." CONCLUSION: IT WOULD APPEAR THAT EITHER PROPER PT TRANSFER PROTOCOLS WHICH REQUIRE THE HOSPITAL BED BRAKES TO BE APPLIED BEFORE A TRANSFER COMMENCES WERE NOT ADHERED TO, OR THAT THE BRAKES ON THE BED WERE FAULTY. MY INVESTIGATION ALSO FOUND THAT THE HOVERMATT WAS OPERATING CORRECTLY AT THE TIME OF THE INCIDENT AND WAS INFLATED FIRMLY THOUGH TO SUPPORT THE PT AS THEY FELL. IT WAS ALSO SAID THAT THE HOVERMATT HAD IN FACT SAVED THE PATENT FROM RECEIVING A MUCH WORSE INJURY. IF THE PT HAD BEEN ON ANY OTHER TRANSFER DEVICE, THEY WOULD HAVE FALLEN DIRECTLY ONTO THE FLOOR.

    Description of Event or Problem · 1

    (B)(6) WAS DROPPED TO THE FLOOR WHILE BEING TRANSFERRED FROM HOSPITAL BED TO X-RAY TABLE 3 DAYS AFTER HAVING BILATERAL HIP REPLACEMENT. COULD HAVE BEEN OPERATOR ERROR OR EQUIPMENT FAILURE. DAMAGE TO LEFT HIP RESULTING IN BEING IN HOSPITAL A MONTH LONGER THAN EXPECTED, AND NEEDING TWO EXTRA OPERATIONS." THE EQUIPMENT FAILURE MENTIONED ABOVE IS THAT OF THE HOSPITAL BED BRAKES.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization