BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-STANDARD

    MDR report key: 2913225 · Received January 8, 2013

    Report

    Report Number
    1518293-2012-00244
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 12, 2012
    Report Date
    January 8, 2013
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BIOMED REPORTED TO PRODUCT MONITORING THAT HE REPLACED THE GENERATOR CONSOLE AND THE SYSTEM IS NOW FUNCTIONING NORMALLY WITH NO CURRENT ISSUE TO REPORT. BIOMED REPORTED NO ISSUE WITH POWER TO THE COLLIMATOR. NO SIMILAR ISSUE PREVIOUSLY, ALTHOUGH, BIOMED DOES MOST REPAIR THROUGH A 3RD PARTY SERVICE.

    Description of Event or Problem · 1

    ON (B)(6): CUSTOMER REPORTS THAT SYSTEM LOST THE ABILITY TO FLUORO DURING AN CYSTO AND URETEROSCOPY PROCEDURE ON A PT. PT AGE AND GENDER ARE NOT KNOWN. PHYSICIAN COMPLETED PROCEDURE WITHOUT FLUORO AND ORDERED X-RAY AFTER PROCEDURE TO VERIFY PLACEMENT. NO INJURIES TO THE PT WERE REPORTED. FACILITY HAS BACK-UP CAPABILITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10102 HUT EXT DR FINAL ASSY-STANDARD IXR LIEBEL-FLARSHEIM CO. HUT EXT DE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK