BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-STANDARD

    MDR report key: 3915272 · Received May 27, 2014

    Report

    Report Number
    1518293-2014-00057
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    LIEBEL-FLARSHEIM COMPANY
    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) TROUBLESHOT AND FOUND MONITOR POWER SUPPLY WAS NOT WORKING. FSE REPLACED POWER SUPPLY AND TESTED PER SPECIFICATIONS IN MANUAL. COMPLETED SERVICE CHECKLIST AND RETURNED UNIT TO FULL SERVICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS BOTH TABLE MONITORS FAILED DURING A CYSTOGRAPHY EXAM. STAFF WAS ABLE TO FINISH THE PROCEDURE WITH AN ENDOSCOPE AND CONNECTING PORTABLE MONITORS TO THE CYSTO TABLE TO VIEW IMAGES. NO PATIENT INJURY. NO OTHER PATIENT DETAILS ARE KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311914 HUT EXT DR FINAL ASSY-STANDARD IXR LIEBEL-FLARSHEIM COMPANY HUT EXT DR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK