BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILHOUETTE 20 HF

    MDR report key: 1081561 · Received July 25, 2008

    Report

    Report Number
    2126677-2008-00053
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    May 11, 2008
    Report Date
    May 11, 2008
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    IZO
    PMA / PMN Number
    K905799
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBLEM WAS DISCOVERED DURING A GE FIELD ENGINEER'S (FE) MAINTENANCE OF A DIFFERENT EQUIPMENT. THE FE EVALUATED THE SYSTEM AND FOUND A FAILED RESISTOR THAT PREVENTED THE TABLE LOCKS FROM ENGAGING, THUS SIMULATING A TABLE FLOAT COMMEND. THE FE REPLACED RESISTOR AND VERIFIED THAT THE TABLE LOCKS WERE PERFORMING ACCORDING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TABLE LOCKS DID NOT ACTUATE, CAUSING THE TABLETOP TO MOVE IN TWO AXES WITHOUT RESISTANCE. THERE WAS NEITHER PT INVOLVEMENT NOR INJURY REPORTED. THIS SITUATION COULD POTENTIALLY CONTRIBUTE TO A SERIOUS INJURY IF A PT WERE TO BECOME UNSTEADY AND FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILHOUETTE 20 HF IZO GE MEDICAL SYSTEMS, LLC B3115NG NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA