BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE AC-POWERED PATIENT LIFT

    MDR report key: 2026793 · Received March 17, 2011

    Report

    Report Number
    1525712-2011-00110
    Event Type
    Other
    Date Received
    March 17, 2011
    Date of Event
    March 5, 2009
    Report Date
    March 16, 2011
    Manufacturer
    LAND AMERICA HEALTH & FITNESS
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERIOUS INJURY ALLEGED. PRODUCT WAS APPROX 3.5 YEARS OLD AT TIME OF INCIDENT WITH NO PREVIOUS COMPLAINTS. MAINTENANCE HISTORY IS UNK. THE NURSE STATED THAT THE RELEASE BUTTON LOWERED THE CONSUMER TOO FAST. THE LIFT DOES NOT HAVE A RELEASE BUTTON BUT A CONTROL VALVE THAT IS USED TO LOWER AN INDIVIDUAL IN THE LIFT. THE CONTROL VALVE HAS A SAFETY GATE CONTROLLING THE DESCENT. NO RISK OF INJURY TO THE CONSUMER IS PRESENT. OPERATOR'S GUIDE HAS INSTRUCTIONS ON THE PROPER AND SAFE USE OF THE PRODUCT. INCIDENT IS MOST LIKELY DUE TO A TRANSFER ERROR. THE DEALER HAS BEEN CONTACTED SEVERAL TIMES FOR RETURN OF THE PRODUCT FOR AN EVALUATION. DEALER HAS NOT RESPONDED. MALFUNCTION NOT CONFIRMED.

    Description of Event or Problem · 1

    THE NURSE ALLEGES WHEN THE CONSUMER WAS BEING TRANSFERRED FROM HER CHAIR, THE RELEASE BUTTON ON THE LIFT ALLEGEDLY RELEASED TOO FAST. THE CONSUMER ALLEGEDLY FELL OUT OF THE SLING TO THE FLOOR, BRUISING HER RIGHT ARM AND BUMPING HER HEAD. NO SERIOUS INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE AC-POWERED PATIENT LIFT 880.5510 FSA LAND AMERICA HEALTH & FITNESS 9805

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR