BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-ARM

    MDR report key: 1842609 · Received September 1, 2010

    Report

    Report Number
    1720753-2010-02902
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    July 6, 2010
    Report Date
    September 1, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE SPECIFIC PART REPLACED WAS NOT DISCLOSED. HOWEVER, THE SYSTEM WAS OPERATING PROPERLY FOLLOWING A FILE ANALYSIS AND REPLACEMENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM WAS OVERHEATING AND COULD NOT BE USED. NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-ARM FLUOROSCOPY XRAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1