BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 5039652 · Received August 28, 2015

    Report

    Report Number
    1518293-2015-00086
    Event Type
    Malfunction
    Date Received
    August 28, 2015
    Date of Event
    August 25, 2015
    Report Date
    August 25, 2015
    Manufacturer
    LIEBEL FLARSHEIM
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) HAD CALLED THE SITE AND THEY IMMEDIATELY CANCELED THE TICKET SAYING THAT IT WAS OPERATOR ERROR. CUSTOMER SAID THEY HAD AN UNTRAINED TECH USING THE SYSTEM OVER THE WEEKEND AND HE HAD THE MONITORS OUT OVER THE X-RAY FIELD WHICH WOULD GIVE THE TABLE MESSAGE, "THE MONITOR MAY BE BLOCKING THE X-RAY FIELD." CUSTOMER SAID THAT THE SYSTEM WAS WORKING AND X-RAYING WITHOUT ISSUE.

    Description of Event or Problem · 1

    CUSTOMER STATED DURING AN UNKNOWN PROCEDURE THE FLUORO FAILED. STAFF WAS ABLE TO MOVE THE PATIENT AND COMPLETE THE PROCEDURE WITH A C-ARM. NO REPORTED INJURY. NO ADDITIONAL DETAILS ARE KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573267 HUT EXT DR FINAL ASSY-REVERSE HUT EXT DR FINAL ASSY-REVERSE IXR LIEBEL FLARSHEIM HUT EXT DR FINAL ASSY-REVERSE

    Patients

    Seq Age Sex Outcome Treatment
    1