BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-ARM

    MDR report key: 1800049 · Received August 11, 2010

    Report

    Report Number
    9617766-2010-00457
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    June 25, 2010
    Report Date
    August 11, 2010
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD. (GE PRIVATE)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE CCD CAMERA WAS REPLACED AND ADJUSTED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM FAILED TO DISPLAY AN IMAGE. NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-ARM FLUOROSCOPY X-RAY JAA GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD. (GE PRIVATE) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1