BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOVERMATT LATERAL PATIENT TRANSFER DEVICE

    MDR report key: 1740722 · Received June 17, 2010

    Report

    Report Number
    2531468-2010-00001
    Event Type
    Other
    Date Received
    June 17, 2010
    Date of Event
    May 16, 2010
    Report Date
    June 16, 2010
    Manufacturer
    D.T. DAVIS ENTERPRISES LTD.
    Product Code
    FRZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L MFR DATE: 08/16/2007. WE, D.T. DAVIS ENTERPRISES, WERE NOTIFIED OF THE INCIDENT ON (B)(6) 2010. TWO HOVERMATTS WERE ON TRIAL AT THE FACILITY WHERE THE INCIDENT OCCURRED. TRAINING WAS PROVIDED BY OUR SALES REPRESENTATIVE, BEFORE THE HOVERMATTS WERE PUT INTO SERVICE AT (B)(6). UPON NOTIFICATION OF THE INCIDENT, BOTH HOVERMATTS WERE REMOVED FROM USE BY OUR SALES REPRESENTATIVE. THE MATTS WERE RETURNED TO THE US ON (B)(6) 2010 AND (B)(6) WAS CONTACTED FOR ADDITIONAL INFORMATION. THE CLINICAL MANAGER SUPPLIED THE INFORMATION INCLUDED IN THIS REPORT ON (B)(6) 2010. IT IS UNCERTAIN WHICH ONE OF THE HOVERMATTS WAS INVOLVED IN THE INCIDENT, SO BOTH MATTS WERE INSPECTED AND FUNCTIONALLY TESTED PER OUR QUALITY ASSURANCE PROCEDURE. WHEN TESTED, BOTH HOVERMATTS FUNCTIONED PROPERLY AND NO DEFECTS WERE FOUND. THE REPORTED INCIDENT COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    TWO CAREGIVERS WERE USING A HOVERMATT TO TRANSFER A PATIENT FROM A HOSPITAL BED TO AN AIR MATTRESS. ONCE THE PATIENT WAS OVER ON THE NEW BED, THE HOVERMATT SUDDENLY POPPED OUT FROM UNDER THE PATIENT AND PUSHED THE PATIENT TO THE EDGE OF THE BED AND THE PATIENT FELL IN BETWEEN THE TWO BEDS ONTO THE FLOOR.

    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. HM34HS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization KINAIR II AIR BED