BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-STANDARD

    MDR report key: 4192540 · Received October 22, 2014

    Report

    Report Number
    1518293-2014-00135
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 7, 2014
    Manufacturer
    LIEBEL FLARSHEIM
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY BIOMED CALLED LF SERVICE SAYING HE HAD ORDERED AND RECEIVED A MONITOR POWER SUPPLY FOR THE TABLE MONITORS AND WAS PLANNING TO INSTALL IT HIMSELF, BUT WANTED TO KNOW WHERE IT WAS LOCATED IN THE TABLE. MALLINCKRODT TECHNICAL SERVICE EXPLAINED WHERE THE POWER SUPPLY FOR THE TABLE MONITORS WAS LOCATED. FIELD SERVICE ENGINEER (FSE) FOLLOWED UP WITH THE BIOMED WHO SAID THAT HE WAS ABLE TO FIND AND REPLACE THE OLD POWER SUPPLY WITH THE NEW ONE. CUSTOMER REPAIR.

    Description of Event or Problem · 1

    CUSTOMER REPORTS VIA PHONE THAT DURING AN UNDETERMINED UROLOGY PROCEDURE, THE SYSTEM FLUORO FAILED. CUSTOMER WOULD PROVIDE NO FURTHER PATIENT OR PROCEDURAL INFORMATION, OTHER THAN TO SAY THE PATIENT IS FINE. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672367 HUT EXT DR FINAL ASSY-STANDARD IXR IXR LIEBEL FLARSHEIM

    Patients

    Seq Age Sex Outcome Treatment
    1