BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-STANDARD

    MDR report key: 3193193 · Received June 25, 2013

    Report

    Report Number
    1518293-2013-00145
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 25, 2013
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) INVESTIGATED COMPLAINT AND FOUND THE TABLE X-RAY MONITOR DID HAVE A VIDEO DISPLAY, BUT THE SIGNAL FROM THE INFIRMED COMPUTER TO THE MONITOR HAD FAILED. FSE TROUBLESHOT THIS TO A BAD CONNECTION, REPAIRED THE CONNECTION AND THE ISSUE WAS RESOLVED. FSE COMPLETED SYSTEM CHECKOUT PER SERVICE CHECKLIST QSSRWI4.1 AND RETURNED THE UNIT TO CUSTOMER FOR FULL SERVICE.

    Description of Event or Problem · 1

    (B)(4): CUSTOMER REPORTS VIA PHONE THAT DURING A RETROGRADE CYSTOGRAM WITH STENT PLACEMENT, ON A FEMALE (AGE UNK), THE SYSTEM FLUORO MONITOR FAILED. PHYSICIAN USED THE CONTROL MONITOR FOR VIEWING OF FLUORO IMAGES AND PROCEDURE WAS COMPLETED WITHOUT INCIDENT. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288647 HUT EXT DR FINAL ASSY-STANDARD IXR LIEBEL-FLARSHEIM CO. HUT EXT DR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK