BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 3871336 · Received April 22, 2014

    Report

    Report Number
    1518293-2014-00045
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Date of Event
    March 31, 2014
    Report Date
    March 31, 2014
    Manufacturer
    LIEBEL FLARSHEIM
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FSE TROUBLESHOT THE REPORTED NO FLUORO ISSUE AND RESOLVED BY REPLACING THE GENERATOR CONSOLE. FSE VERIFIED PROPER OPERATION PER SERVICE CHECKLIST AND RETURNED TO UNIT TO SERVICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS VIA PHONE THAT DURING AN UNDETERMINED UROLOGY PROCEDURE, THE SYSTEM FLUORO FAILED. STAFF BROUGHT IN A PORTABLE C-ARM FLUORO UNIT AND COMPLETED THE PROCEDURE WITHOUT FURTHER INCIDENT. CUSTOMER PROVIDED NO FURTHER PATIENT OR PROCEDURAL INFO, OTHER THAN TO SAY THE PATIENT IS FINE. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244157 HUT EXT DR FINAL ASSY-REVERSE IXR LIEBEL FLARSHEIM HUT EXT DR FINAL A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK