BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-STANDARD

    MDR report key: 3140060 · Received May 29, 2013

    Report

    Report Number
    1518293-2013-00127
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 29, 2013
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN FIELD SERVICE ENGINEER (FSE) ARRIVED ON SITE, THE SYSTEM WAS WORKING. FSE TROUBLESHOT THE REPORTED ERROR MESSAGE AND FOUND BLOOD AND FLUIDS IN THE TUB. AFTER HOUSEKEEPING CLEANED THE BLOOD, FSE CONTINUED CLEANING AND INSPECTING THE TUB AND FOUND RESIDUE ON THE AMP BOARD FOR THE IMAGE SYSTEM. THIS WAS THE REASON FOR THE MISALIGNMENT ERROR. FSE REPLACED THE AMP BOARD DUE TO CONTAMINATION AND CHECKED SYSTEM FOR PROPER OPERATION ACCORDING TO SERVICE CHECKLIST QSSRWI4.1 AND SYSTEM SERVICE MANUALS. UNIT PASSED CHECKOUT PROCEDURES AND WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, CUSTOMER STATES VIA PHONE THAT DURING A PERCUTANEOUS NEPHROLITHOTOMY THE FLUORO FAILED. THE PHYSICIAN MOVED THE (B)(6) MALE PT TO ANOTHER ROOM TO COMPLETE THE PROCEDURE. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233913 HUT EXT DR FINAL ASSY-STANDARD IXR LIEBEL-FLARSHEIM CO. HUT EXT DR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR