BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 4222996 · Received November 4, 2014

    Report

    Report Number
    1518293-2014-00140
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 10, 2014
    Manufacturer
    LIEBEL FLARSHEIM
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MALLINCKRODT TECH SERVICE RECEIVED A CALL FROM (B)(4), WHO SAID THE OPERATOR REPORTED THE SYSTEM WOULD NOT FLUORO. (B)(4) TOLD TECH SERVICE THAT HE HAD CYCLED POWER ON EVERYTHING PRIOR TO CALLING, SO AT THIS POINT TECH SERVICE COULD NOT TROUBLESHOOT WITH (B)(4) TO DETERMINE IF EVERYTHING WAS SET UP PROPERLY, AND IF A PATIENT FILE HAD BEEN OPENED TO ACQUIRE. TECH SERVICE DID HAVE (B)(4) ATTEMPT TO FLUORO, AND THE SYSTEM APPEARED FULLY FUNCTIONAL. WE CANNOT EXPLAIN WHY THE SYSTEM DID NOT ALLOW FLUORO AT THE TIME, BUT PER (B)(4), IT IS WORKING AS EXPECTED. MALLINCKRODT PRODUCT MONITORING CALLED CUSTOMER FOR ADDITIONAL INFORMATION, AND CUSTOMER REPORTED, "THEY ORDERED A VERY EXPENSIVE PIECE OF EQUIPMENT, AND THE ROOM IS WORKING, BUT WOULD PROVIDE NO FURTHER INFORMATION. A REVIEW SHOWS NO SIMILAR ISSUE REPORTED ON THIS UNIT. CUSTOMER REPAIR.

    Description of Event or Problem · 1

    CUSTOMER REPORTS VIA PHONE THAT STAFF WERE ATTEMPTING TO PERFORM AN UNDETERMINED UROLOGY PROCEDURE, WHEN THE SYSTEM FAILED. PHYSICIAN CANCELLED THE PROCEDURE, UNTIL THE ROOM WAS REPAIRED. CUSTOMER WOULD NOT PROVIDE ANY FURTHER INFORMATION ABOUT THE PATIENT OR PROCEDURE. ONLY REPORTS THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708123 HUT EXT DR FINAL ASSY-REVERSE IXR IXR LIEBEL FLARSHEIM

    Patients

    Seq Age Sex Outcome Treatment
    1