BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-STANDARD

    MDR report key: 2922012 · Received January 15, 2013

    Report

    Report Number
    1518293-2013-00012
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    January 7, 2012
    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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) WENT ON SITE AND FOUND THE PROBLEM WAS CAUSED BY A DAMAGED FOOTSWITCH CABLE. FSE REPLACED THE FOOTSWITCH AND VERIFIED PROPER OPERATION PER HUT SERVICE CHECKLIST QSSRWI4.1. UNIT PASSED CHECKOUT PROCEDURES AND WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, CUSTOMER STATES VIA PHONE THE SYSTEM LOST FLUORO DURING A CYSTOGRAM. THE PHYSICIAN CANCELLED THE CASE AND WILL BRING THE PT BACK ANOTHER DAY. THERE WAS NO REPORTED INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22556 HUT EXT DR FINAL ASSY-STANDARD IXR LIEBEL-FLARSHEIM CO. HUT EXT DR NA

    Patients

    Seq Age Sex Outcome Treatment
    1