BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 3871337 · Received April 22, 2014

    Report

    Report Number
    1518293-2014-00047
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    LIEBEL FLARSHEIM
    Product Code
    IXR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) TROUBLESHOT AND FOUND THE FLUORO WAS OPERATIONAL. THE PROBLEM WAS WITH THE MONITOR'S POWER SUPPLY. FSE REPLACED THE MONITOR'S POWER SUPPLY PER HYDAJUST DR SERVICE MANUAL AND COMPLETED SERVICE CHECKLIST. UNIT PASSED CHECKOUT PROCEDURES AND WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS VIA PHONE THAT DURING A UROLOGY CYSTOGRAM, THE SYSTEM FLUORO FAILED. STAFF BROUGHT IN A PORTABLE C-ARM FLUORO UNIT AND COMPLETED THE PROCEDURE WITHOUT FURTHER INCIDENT. NO REPORTED INJURY. CUSTOMER WOULD NOT PROVIDE ANY FURTHER INFO WITH REGARDS TO PATIENT OR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244147 HUT EXT DR FINAL ASSY-REVERSE IXR LIEBEL FLARSHEIM HUT EXT DR FINAL A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK