BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 2042349 · Received February 15, 2011

    Report

    Report Number
    9617766-2011-00614
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 15, 2011
    Manufacturer
    GE MED SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR'S SVC REP PERFORMED AN ONSITE INVESTIGATION. THE INTERNAL CRADLE CABLE WAS REPLACED. THE SYS WAS TESTED AND OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PRECHARGE ERROR MESSAGE ON THE 8800 SYS. 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 (GE PRIVATE) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1