BEUDAMED
    FDA Adverse Event Summary report: N

    8030916-2009-00004

    MDR report key: 1346810 · Received March 9, 2009

    Report

    Report Number
    8030916-2009-00004
    Date Received
    March 9, 2009
    Product Code
    FSA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION ON THE RETURNED LIKORALL MOTOR, SHOWED THAT THE MECHANICAL STOP ON THE MOTOR HAD BEEN MOVED, ALLOWING AN OVERLOAD ON THE GEARBOX. THIS PUT THE LIMIT SWITCH ON THE LIFT OUT OF ORDER WHICH WOULD HAVE PREVENTED THIS INCIDENT FROM OCCURRING. THE SFS (SINGLE FAULT SAFETY) SYSTEM WAS TESTED AND FOUND OPERATIONAL ACCORDING TO SPECS. THEREFORE, THE RISK OF INJURY TO THE PT WAS EXTREMELY LOW.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1