BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 2883125 · Received December 18, 2012

    Report

    Report Number
    1518293-2012-00239
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    December 11, 2012
    Report Date
    December 18, 2012
    Manufacturer
    LIEBEL-FLARSHEIM BUSINESS
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN FIELD SERVICE ENGINEER (FSE) CONFIRMED REPORT OF SYSTEM MISALIGNMENT WHICH ENGAGED THE SAFETY INTERLOCK AND DID NOT ALLOW FLUORO. FSE EVALUATED THE MISALIGNMENT PROBLEM AND FOUND A CORRODED IMAGE INTENSIFIER TRANSDUCER AMPLIFIER BOARD. FSE REPLACED THE BOARD, ADJUSTED TUBE AND IMAGE INTENSIFIER ALIGNMENT SETTINGS. FSE THEN DETERMINED THE TABLE WAS STILL NOT TRACKING CORRECTLY WITH TUBE, AND FSE TOLD CUSTOMER THEY MAY NEED THE IMAGE INTENSIFIER TRANSDUCER REPLACED. THE CUSTOMER DECLINED THE IMAGE INTENSIFIER TRANSDUCER PART REPLACEMENT AT THIS TIME SINCE THE TABLE WAS WORKING AND ALIGNING CORRECTLY AT THE FOOT END, BUT JUST NOT AS WELL AT THE HEAD END. FSE VERIFIED PROPER OPERATION USING SERVICE MANUALS.

    Description of Event or Problem · 1

    ON (B)(6): CUSTOMER REPORTS VIA PHONE THAT DURING AN UNDETERMINED UROLOGY PROCEDURE, THE SYSTEM FLUORO FAILED. STAFF MOVED THE PATIENT TO ANOTHER ROOM, WHERE PHYSICIAN COMPLETED THE PROCEDURE WITHOUT FURTHER INCIDENT. CUSTOMER DID NOT PROVIDED PATIENT OR PROCEDURE INFO OTHER THAN TO STATE THE PATIENT IS FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK