BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-STANDARD

    MDR report key: 3130146 · Received May 21, 2013

    Report

    Report Number
    1518293-2013-00109
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 26, 2013
    Report Date
    May 21, 2013
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER CALLED SERVICE REPORTING THE FLUORO TIMER WAS RUNNING BY ITSELF. AFTER 5 MINUTES, STAFF TURNED THE SYSTEM OFF TO STOP FLUORO. CUSTOMER DID NOT CALL FOR A FIELD SERVICE ENGINEER TO VISIT. PRODUCT MONITORING CALLED CUSTOMER AND BIOMED REPORTED AFTER INSPECTING THE SYSTEM, HE WAS UNABLE TO GET THE SYSTEM TO FLUORO ON ITS OWN. THE SYSTEM WAS STILL IN FULL USE AT THE SITE. QUALITY SPOKE WITH RESEARCH AND DEVELOPMENT PRODUCTION ENGINEER (B)(6) AND PRODUCTION ENGINEER (B)(6) WHO SAID THERE WAS NO KNOWN ISSUE OR SOFTWARE ANOMALY ON THIS SYSTEM THAT WOULD CAUSE THIS TO OCCUR.

    Description of Event or Problem · 1

    (B)(6) 2013 CUSTOMER REPORTS VIA PHONE THAT DURING A TURP (TRANSURETHRAL RESECTION OF THE PROSTATE) PROCEDURE THAT DOES NOT REQUIRE FLUOROSCOPY THE FLUORO STARTED BY ITSELF. THE RN WAS PUTTING PATIENT INFORMATION IN THE COMPUTER WHEN SHE NOTICED THE FLUORO TIMER STARTED AND THE RADIATION EMISSION SYMBOL LIT UP. THE FLUORO WAS ON FOR 5 MINUTES BEFORE THE STAFF TURNED THE SYSTEM OFF TO STOP THE FLUORO. THE PATIENT WAS MALE OF UNKNOWN AGE. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225272 HUT EXT DR FINAL ASSY-STANDARD IXR LIEBEL-FLARSHEIM CO. HUT EXT DR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK