BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2850583 · Received November 27, 2012

    Report

    Report Number
    1720753-2012-09692
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 27, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE POWER CONNECTOR ON THE POWER CONTROL PCB WAS TIGHTENED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT TURN ON WHEN PLUGGED IN, THUS IT WOULD NOT BOOT UP. THERE IS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1