BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2742357 · Received September 5, 2012

    Report

    Report Number
    1720753-2012-06918
    Event Type
    Malfunction
    Date Received
    September 5, 2012
    Date of Event
    August 20, 2012
    Report Date
    September 5, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND CLEANED AND RE-LUBRICATED THE HIGH VOLTAGE CANDLESTICK CONNECTORS. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WAS ARCING AND SHUT DOWN WITHOUT COMMAND. THERE IS NO REPORT OF PATIENT INJURY OR DEATH.

    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