BEUDAMED
    FDA Adverse Event Other Summary report: N

    8030916-2008-00032

    MDR report key: 1150031 · Received August 29, 2008

    Report

    Report Number
    8030916-2008-00032
    Event Type
    Other
    Date Received
    August 29, 2008
    Product Code
    FSA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTION SHOWS THAT THE EVENT WAS CAUSED BY THE BRAKE OF THE MOTORSHAFT. THE SFS (SINGLE FAULT SYSTEM) WAS TESTED ON THE EVENT LIFT AND FOUND WORKING ACCORDING TO SPECS. THE SFS WILL PREVENT ANY SERIOUS INJURY IF A FAILURE IN THE DRIVING LINE (MOTOR, GEARBOX) WOULD OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FSA

    Patients

    Seq Age Sex Outcome Treatment
    1