BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOVERMATT LATERAL PATIENT TRANSFER DEVICE

    MDR report key: 2501425 · Received January 5, 2012

    Report

    Report Number
    2531468-2011-00003
    Event Type
    Other
    Date Received
    January 5, 2012
    Date of Event
    November 30, 2011
    Report Date
    December 20, 2011
    Manufacturer
    D.T. DAVIS ENTERPRISES LTD. T/A HOVERTECH INTERNATIONAL
    Product Code
    FRZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) STATED IN AN E-MAIL: "I BELIEVE THAT THE INCIDENT WITH THE HOVERMATT WAS USER ERROR. I DO NOT THINK IT IS A FAULTY EQUIPMENT ISSUE." THE DEVICE WAS NOT REMOVED FROM SERVICE. SINCE THE HOVERMATT WAS NOT THE CAUSE OF THE INCIDENT, IT WAS NOT RETURNED TO HOVERTECH INTERNATIONAL FOR EVALUATION. WE HAVE BEEN IN COMMUNICATION WITH FACILITY AND HAVE ARRANGED FOR A RE-TRAINING SESSION ON JANUARY 17, 2912 AT THE FACILITY. A SALES REPRESENTATIVE FROM D.T. DAVIS WILL BE LEADING THE TRAINING AND EMPHASIZING THE CORRECT ERGONOMICS OF USING THE HOVERMATT.

    Description of Event or Problem · 1

    LPN IN (B)(6) MEDICAL CENTER BURN UNIT TRANSFERRING PT FROM STRETCHER TO BED USING HOVERMATT SINGLE PT USE AND 2 - 3 ADDITIONAL STAFF. FELT A MINOR SHOULDER PULL (NO PAIN) WHEN SHE WENT TO REACH HOVERMATT HANDLE. LATER IN THE DAY BECAME AN ACHE, NO LOST TIME, NO PHYSICAL RESTRICTIONS AT 2 DAYS POST. NOW HAS PHYSICAL RESTRICTIONS AS OF THIS DATE, (B)(6) 2011. MEDICAL FOLLOWED AND TREATED BY (B)(6) DEPARTMENT.

    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 HM34SPU

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention