BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 2170987 · Received June 30, 2011

    Report

    Report Number
    1720753-2011-08660
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 30, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED ON ONSITE INVESTIGATION. THE SVC REP REPLACED THE BATTERY CHARGER PRINTED CIRCUIT BOARD, AND CHECKED THE VOLTAGE. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SVC.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD DISPLAY A FAILED CHARGER 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 OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1