BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 4242397 · Received November 11, 2014

    Report

    Report Number
    1518293-2014-00137
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 13, 2014
    Report Date
    May 26, 2015
    Manufacturer
    LIEBEL FLARSHEIM
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION. UPON RECEIPT OF INVESTIGATION, A MEDWATCH 3500A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) INVESTIGATED REPORT THAT THE GENERATOR CONSOLE WOULD NOT POWER UP. FSE REPLACED THE GENERATOR CONSOLE, TRANSFERRED THE FLASH CHIP FROM THE OLD CONSOLE TO THE NEW CONSOLE, PROGRAMMED THE CONSOLE, AND SYNCED THE CONSOLE TO THE GENERATOR. FSE TESTED THE SYSTEM PER SERVICE CHECKLIST AND FINDING NO PROBLEMS, RETURNED THE UNIT TO FULL SERVICE. 5/26/15: MFG FINDS THE UNIT LOCKS UP BECAUSE THE FANS FOR THE CPU STOPS, CAUSING THE SYSTEM TO OVERHEAT.

    Description of Event or Problem · 1

    CUSTOMER REPORTS VIA PHONE THAT DURING AN UNDETERMINED UROLOGY PROCEDURE, THE SYSTEM FLUORO FAILED. STAFF COMPLETED THE PROCEDURE USING ENDOSCOPY. CUSTOMER PROVIDED NO FURTHER INFORMATION, OTHER THAN TO SAY THE PATIENT IS FINE. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726933 HUT EXT DR FINAL ASSY-REVERSE IXR IXR LIEBEL FLARSHEIM

    Patients

    Seq Age Sex Outcome Treatment
    1