BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 3193191 · Received June 25, 2013

    Report

    Report Number
    1518293-2013-00146
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 25, 2013
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) INVESTIGATED COMPLAINT FINDING THE GENERATOR WAS NOT COMPLETING THE POWER UP SEQUENCE. FSE FOUND THE SOFTWARE WAS CORRUPT AND REPLACED THE SIM CHIP IN THE CONSOLE. FSE THEN VERIFIED PROPER OPERATION IN ACCORDANCE WITH SERVICE CHECK LIST QSSRWI4.1 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 SYSTEM FLUORO FAILED. STAFF MOVED THE PATIENT TO ANOTHER ROOM WHERE THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. CUSTOMER DECLINED TO PROVIDE PROCEDURAL OR PATIENT INFORMATION, OTHER THAN TO SAY THE PATIENT WAS FINE. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288805 HUT EXT DR FINAL ASSY-REVERSE IXR LIEBEL-FLARSHEIM CO. HUT EXT DR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK