BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFTEM MARK IV

    MDR report key: 911025 · Received September 7, 2007

    Report

    Report Number
    1058908-2007-00002
    Event Type
    Other
    Date Received
    September 7, 2007
    Date of Event
    March 17, 2007
    Report Date
    September 5, 2007
    Manufacturer
    MILLENNIUM MEDICAL PRODUCTS, INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON SEPTEMBER 5, 2007, (RENTAL DISTRIBUTOR OF MEDICAL DEVICE) INFORMED MILLENNIUM MEDICAL PRODUCTS, INC. (MANUFACTURER OF MEDICAL DEVICE) OF THE FOLLOWING INCIDENT. ON APPROX FIVE AND A HALF MONTHS EARLIER, DISTRIBUTOR WAS NOTIFIED BY DIRECTOR OF NURSING AT NURSING CENTER, THAT A PATIENT WAS INJURED DURING A TRANSFER WHEN THE LIFT TIPPED OVER DURING USE. THE TYPE OF BED THE PATIENT WAS ON WAS BLAMED, AND NO FURTHER INFORMATION WAS PROVIDED TO DISTRIBUTOR BY THE FACILITY. DIST TESTED THE MEDICAL DEVICE AND FOUND NO PROBLEMS WITH IT. THEY THEN PROVIDED FOLLOW-UP IN-SERVICE STAFF TRAINING TO ASSURE PROPER OPERATION OF THE DEVICE. PROBABLE CAUSE OF INCIDENT IS USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFTEM MARK IV PATIENT LIFT AND TRANSFER DEVICE FSA MILLENNIUM MEDICAL PRODUCTS, INC. LFT700 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other