BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2884844 · Received December 3, 2012

    Report

    Report Number
    1720753-2012-09909
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 30, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION, THE JOYSTICK WAS REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE REMOTE CONTROL ARM (REMOTE USER INTERFACE/JOYSTICK) WAS NOT WORKING. WHEN THE MOTORIZED MOVEMENTS ARE COMPLETELY DOWN, THE CRANIAL AND CAUDAL MOVEMENTS ARE NOT AVAILABLE RENDERING THE SYSTEM UNUSABLE FOR ITS SPECIFIC DESIGN. THERE IS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1