BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-ARM

    MDR report key: 1831903 · Received September 8, 2010

    Report

    Report Number
    9680959-2010-00317
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    June 21, 2010
    Report Date
    September 8, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED INTERMITTENTLY THE MONITOR FAILED TO OPERATE. NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-ARM FLUOROSCOPY XRAY JAA GE OEC MEDICAL SYSTEMS GMBH 7700

    Patients

    Seq Age Sex Outcome Treatment
    1