BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 5002676 · Received August 13, 2015

    Report

    Report Number
    1518293-2015-00073
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    July 27, 2015
    Report Date
    July 27, 2015
    Manufacturer
    LIEBEL FLARSHEIM
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) INVESTIGATED REPORT THAT THE SYSTEM WOULD NOT FLUORO AND FOUND THE SOMEONE HAD DISABLED FLUORO ON THE CONFIGURATION SCREEN IN THE INFIMED COMPUTER. FSE CORRECTED THIS SETTING, CHECKED THE UNIT FOR PROPER OPERATION PER SERVICE CHECKLIST (B)(4) AND RETURNED THE UNIT TO THE CUSTOMER FOR SERVICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS DURING AN UNKNOWN PROCEDURE THE SYSTEM FLUORO FAILED. STAFF WAS ABLE TO COMPLETE THE PROCEDURE WITH ENDOSCOPY. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534841 HUT EXT DR FINAL ASSY-REVERSE HUT EXT DR IXR LIEBEL FLARSHEIM HUT EXT DR FINAL ASSY-REVERSE

    Patients

    Seq Age Sex Outcome Treatment
    1