BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600+

    MDR report key: 1173000 · Received September 19, 2008

    Report

    Report Number
    1720753-2008-26101
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 19, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP ORDERED A NEW HARD DRIVE. THE SYSTEM WAS OPENED IN ERROR AS A 9800. THE CASE WAS CORRECTED TO A 9600 ONCE IDENTIFIED ON SITE. THE REP INSPECTED THE SYSTEM AND FOUND SYSTEM KEY PAD NOT FUNCTIONING PROPERLY. HE SHUT DOWN THE SYSTEM AND RESEATED ALL RELATIVE CONNECTIONS AND BOARDS. HE RE - CHECKED POWER SUPPLIES AND ALL LOOKS GOOD. HE TESTED THE SYSTEM AGAIN AND COULD NOT REPRODUCE THE PROBLEM. THE SYSTEM IS FUNCTIONING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WAS NOT SAVING IMAGES. NO PATIENT WAS INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9600+ FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1