BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-STANDARD

    MDR report key: 3250053 · Received July 23, 2013

    Report

    Report Number
    1518293-2013-00175
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    July 9, 2013
    Report Date
    July 23, 2013
    Manufacturer
    LIEBEL-FLARSHEIM CO
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SVC ENGINEER (FSE) TROUBLESHOT LOSS OF FLUORO AND FOUND A BROKEN WIRING HARNESS. FSE REPLACED THE WIRING HARNESS AND VERIFIED PROPER OPERATION PER (B)(4). SYS RETURNED TO FULL SVC BY THE CUSTOMER.

    Description of Event or Problem · 1

    ON (B)(6) 2013: CUSTOMER STATES VIA PHONE THAT ALL TABLE FUNCTIONS FAILED AND THE TUBE CARRIAGE ARM WAS STUCK DURING A CYSTO PROCEDURE ON A MALE PT OF UNK AGE. THE PHYSICIAN MOVED THE PT TO ANOTHER TABLE AND COMPLETED THE PROCEDURE WITH A PORTABLE C-ARM FLUORO. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343253 HUT EXT DR FINAL ASSY-STANDARD IXR LIEBEL-FLARSHEIM CO HUT EXT DR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK