BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 2872019 · Received December 11, 2012

    Report

    Report Number
    1518293-2012-00234
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    December 6, 2012
    Report Date
    December 11, 2012
    Manufacturer
    MALLINCKRODT INC., 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

    FIELD SERVICE ENGINEER (FSE) TROUBLESHOT THE ¿NO TABLE MOVEMENT¿ COMPLAINT AND FOUND THAT THE TOWER INTERFACE BOARD WAS NOT ALLOWING TABLE MOVEMENT AND THE Y AXIS TRANSDUCER AMPLIFIER BOARD WAS CORRODED CAUSING THE INTERMITTENT MOVEMENT ERRORS. FSE REPLACED BOTH THE TOWER INTERFACE BOARD AND THE TRANSDUCER PCB ASSEMBLY AND THE TABLE MOVEMENTS RETURNED TO NORMAL. FSE VERIFIED PROPER OPERATION PER (B)(4) AND RETURNED THE UNIT TO THE CUSTOMER FOR FULL SERVICE.

    Description of Event or Problem · 1

    (B)(6): CUSTOMER REPORTS VIA PHONE THAT DURING AN UNDETERMINED UROLOGY PROCEDURE, THE TABLE MOVEMENT FAILED. STAFF MOVED THE PT TO ANOTHER ROOM WHERE THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. CUSTOMER DID NOT PROVIDED ANY PROCEDURAL OR PATIENT INFO OTHER THAN TO STATE THE PROCEDURE WAS COMPLETED AND PATIENT IS FINE. NO REPORTED INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK