BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 2850337 · Received November 26, 2012

    Report

    Report Number
    1720753-2012-09611
    Event Type
    Malfunction
    Date Received
    November 26, 2012
    Date of Event
    August 30, 2012
    Report Date
    November 26, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE BATTERIES WERE REPLACED, HOWEVER, THE QUOTE FOR THE TUBE WAS NOT APPROVED AND THE SYSTEM REMAINS INOPERABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WAS WEAK AND UNABLE TO PERFORM FLUOROSCOPIC X-RAY. THERE IS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1