BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 2101660 · Received May 11, 2011

    Report

    Report Number
    9617766-2011-01030
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    April 26, 2011
    Report Date
    May 11, 2011
    Manufacturer
    GE MED SYSTEMS (INDIA) PRIVATE LTD
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE INSTRUCTED THE CUSTOMER OVER THE PHONE TO RE-TRIGGER THE BATTERY CHARGE CIRCUIT BREAKER. THE ERROR DID NOT OCCUR AGAIN, AND THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A PRELOAD VOLTAGE ERROR MESSAGE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8800 FLUOROSCOPIC X-RAY JAA GE MED SYSTEMS (INDIA) PRIVATE LTD 8800

    Patients

    Seq Age Sex Outcome Treatment
    1