BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 4192528 · Received October 22, 2014

    Report

    Report Number
    1518293-2014-00131
    Event Type
    Malfunction
    Date Received
    October 22, 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
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MALLINCKRODT PRODUCT MONITORING FOLLOW UP; CUSTOMER STATED THAT BIOMED INVESTIGATED FURTHER AND FOUND THE CAMERA IRIS WAS OUT OF TOLERANCE. THEY RECALIBRATED THE CAMERA AND THE SYSTEM IS FUNCTIONING WITHOUT ANY ISSUES. CUSTOMER REPAIR.

    Description of Event or Problem · 1

    CUSTOMER REPORTS VIA PHONE THAT DURING AN UNDETERMINED UROLOGY PROCEDURE, THE FLUORO IMAGE GOT REALLY DARK, AND STAFF HAD TO MOVE THE PATIENT TO ANOTHER ROOM TO COMPLETE THE PROCEDURE. CUSTOMER DID NOT PROVIDE ANY FURTHER PATIENT OR PROCEDURAL INFORMATION, OTHER THAN TO STATE THE PATIENT IS FINE. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672363 HUT EXT DR FINAL ASSY-REVERSE IXR IXR LIEBEL FLARSHEIM

    Patients

    Seq Age Sex Outcome Treatment
    1