BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 1921926 · Received December 8, 2010

    Report

    Report Number
    9617766-2010-00825
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 19, 2010
    Report Date
    December 8, 2010
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND COULD NOT REPRODUCE THE REPORTED PROBLEM. GE REPRESENTATIVE REPAIRED A POWER OUTLET THE SYSTEM HAD BEEN PLUGGED INTO. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM WOULD INTERMITTENTLY QUIT WORKING AND DISPLAY A COMMUNICATION ERROR. SYSTEM OPERATES AS INTENDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1