BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-STANDARD

    MDR report key: 3140066 · Received May 29, 2013

    Report

    Report Number
    1518293-2013-00126
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 29, 2013
    Manufacturer
    LIEBEL - FLARSHEIM CO.
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER CALLED COVIDIEN SERVICE REPORTING THAT THE FLUORO MONITOR WAS BLANK DURING A PROCEDURE. CUSTOMER CALLED BACK SAYING THEY HAD PUSHED A WRONG BUTTON, THAT THE SYSTEM WAS WORKING AND CANCELLED SERVICE CALL. ON THE FOLLOWING DAY, PRODUCT MONITORING CONTACTED CUSTOMER WHO SAID THAT THEY HAD CORRECTED THE VIDEO DISTRIBUTION BOX SETTINGS AFTER THE CASE WAS OVER. APPARENTLY IT WAS AT THAT TIME CUSTOMER DISCOVERED THEIR ERROR.

    Description of Event or Problem · 1

    ON (B)(6) 2013, CUSTOMER STATES VIA PHONE THAT DURING A CYSTO THE FLUORO MONITOR WAS BLANK. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE WITHOUT FLUORO. NO PATIENT DETAILS ARE AVAILABLE. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235468 HUT EXT DR FINAL ASSY-STANDARD IXR LIEBEL - FLARSHEIM CO. HUT EXT DR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK