BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 1475991 · Received July 10, 2009

    Report

    Report Number
    9617766-2009-00445
    Event Type
    Malfunction
    Date Received
    July 10, 2009
    Date of Event
    July 6, 2009
    Report Date
    July 10, 2009
    Manufacturer
    GE MED SYSTEMS INDIA PRIVATE LIMITED
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE GE SERVICE REP REVIEWED THE ERROR LOGS, INTERMITTENT ERROR ON FFB, GBI, SVR NODES. HE CLEARED THE FLASH MEMORY AND RELOADED THE... HE RESEATED THE PCBS AND CABLES IN MONITOR CART AND TESTED NORMAL SYSTEM OPERATION. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DID NOT BOOT UP AND THERE WERE PROBLEMS WITH THE VERTICAL COLUMN. 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 LIMITED NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1