BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X7-2T COMPACT, ROHS

    MDR report key: 3898936 · Received May 21, 2014

    Report

    Report Number
    3019216-2014-00011
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Report Date
    April 22, 2014
    Manufacturer
    PHILIPS ULTRASOUND, INC.
    Product Code
    IYN
    PMA / PMN Number
    K030455
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A PHILIPS FIELD SERVICE ENGINEER WAS DISPATCHED TO EXAMINE THE TEE PROBE WHERE A WIRE PROTRUDING FROM THE TIP SHEATH WAS OBSERVED. THE DAMAGED PROBE WAS RETURNED FOR EVALUATION AND THE INITIAL INVESTIGATION REVEALED A BROKEN AND FRAYED STEERING CABLE CAUSING A SMALL SECTION OF ONE STRAND TO PIERCE THROUGH THE ARTICULATION COVER. THE EXACT CAUSE OF THE DAMAGE TO THE STEERING CABLE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ERROR MESSAGE WHILE PREPARING A TEE FOR USE. THE TEE WAS TAKEN OUT OF SERVICE AND ANOTHER PROBE WAS USED TO PERFORM THE EXAMINATION. NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304082 X7-2T COMPACT, ROHS IYN PHILIPS ULTRASOUND, INC. 989605414121 B0V9ZD

    Patients

    Seq Age Sex Outcome Treatment
    1