BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 4173759 · Received October 15, 2014

    Report

    Report Number
    1518293-2014-00130
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 24, 2014
    Manufacturer
    LIEBEL FLARSHEIM
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTED MONITOR FAILED DURING A PROCEDURE, AND DETERMINED CAUSE WAS DUE TO A BAD DUAL MONITOR POWER CABLE. CUSTOMER ORDERED PART, AND, PER MALLINCKRODT PRODUCT MONITORING'S FOLLOW UP CALL, CUSTOMER RECEIVED THE CABLE, INSTALLED IT AND THE ISSUE WAS RESOLVED. FACILITY BIOMED COMPLETED REPAIR.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THE FLUORO MONITOR FAILED DURING A PATIENT PROCEDURE. STAFF BROUGHT A PORTABLE FLUORO C-ARM INTO THE ROOM AND CONNECTED THE MONITORS TO COMPLETE THE PROCEDURE. NO REPORTED INJURY. NO OTHER PATIENT DETAILS ARE KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654240 HUT EXT DR FINAL ASSY-REVERSE IXR IXR LIEBEL FLARSHEIM

    Patients

    Seq Age Sex Outcome Treatment
    1