BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 3093466 · Received April 26, 2013

    Report

    Report Number
    1720753-2013-05412
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 26, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS UNAVAILABLE. HOWEVER, NO REPORT OF PATIENT OR STAFF INJURY WAS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM WAS FREEZING, LOCKING UP. THE FSE NOTED THE SYSTEM LOCKED UP DURING A PROCEDURE. THERE IS NO REPORT OF PATIENT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181736 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 8800

    Patients

    Seq Age Sex Outcome Treatment
    1