BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3142716 · Received May 24, 2013

    Report

    Report Number
    1720753-2013-06407
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 24, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CANCELED THE SERVICE CALL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WAS INTERMITTENTLY NOT POWERING UP AND THAT THE MONITOR WAS NOT AT ISSUE. THERE IS NO REPORT OF PATIENT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231740 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1