BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOP

    MDR report key: 2844319 · Received November 8, 2012

    Report

    Report Number
    1720753-2012-09205
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Date of Event
    September 7, 2012
    Report Date
    November 8, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AGE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE LEFT MONITOR WAS REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE FIELD ENGINEER REPORTED THAT THE LEFT MONITOR WOULD NOT WORK AT START-UP BUT THEN DID AFTER THE SYSTEM WAS REBOOTED. THIS RESULTED IN AN INTERMITTENT LOSS OF LIVE IMAGE. THERE IS NO REPORT OF PATIENT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1