BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-ARM

    MDR report key: 1800028 · Received August 11, 2010

    Report

    Report Number
    9617766-2010-00455
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    May 5, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE CUSTOMER INDICATED THEY WILL CONDUCT THE REPAIRS THEMSELVES. NO CONCLUSION REGARDING THE REPAIR AND THE OPERATING CONDITION CAN BE DRAWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE RIGHT MONITOR DISPLAYED A WHITE IMAGE SPORADICALLY WHEN IT WAS SWITCHED ON. 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) STENOSCOPE

    Patients

    Seq Age Sex Outcome Treatment
    1