BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-STANDARD

    MDR report key: 2922009 · Received January 15, 2013

    Report

    Report Number
    1518293-2013-00013
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Report Date
    January 15, 2013
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND REPLACED THE GENERATOR CONSOLE. FSE THEN VERIFIED OPERATION THRU NUMEROUS POWER CYCLES AND EXTENDED OPERATIONAL TESTS. FSE ALSO PROVIDED GENERAL OPERATIONAL TRAINING AND SET THE TABLE PERM RECAL POSITION PER STAFF REQUEST. FSE COMPLETED THE SERVICE CHECKLIST (B)(4) AND RETURNED THE SYSTEM TO FULL SERVICE.

    Description of Event or Problem · 1

    ON (B)(6): CUSTOMER REPORTS VIA PHONE THAT SYSTEM FLUORO FAILED DURING A PT PROCEDURE AND STAFF HAD TO BRING A PORTABLE C-ARM FLUORO UNIT IN TO COMPLETE THE PROCEDURE. CUSTOMER WAS NOT ABLE TO PROVIDE ANY PT OR PROCEDURAL INFORMATION, OTHER THAN TO SAY THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22555 HUT EXT DR FINAL ASSY-STANDARD IXR LIEBEL-FLARSHEIM CO. HUT EXT DR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK