BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 2023045 · Received February 24, 2011

    Report

    Report Number
    1720753-2011-01609
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 24, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. A PRINTED CIRCUIT BOARD WAS REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, THE 9600 SYSTEM IS UNABLE TO SAVE IMAGES. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9600 FLUOROSCOPY X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1