BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSDUCER, S8-3T MICRO TEE

    MDR report key: 4210850 · Received August 1, 2014

    Report

    Report Number
    3019216-2014-00016
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 7, 2014
    Manufacturer
    PHILIPS ULTRASOUND, INC.
    Product Code
    IYO
    PMA / PMN Number
    K030455
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A THIRD PARTY EVALUATION OF THE FAILED TRANSDUCER CONCLUDED A DAMAGED LENS CAUSED THE POOR IMAGE QUALITY ISSUE. THE PROCEDURE UNDERWAY WAS COMPLETED SUCCESSFULLY WITH NO INJURY.

    Description of Event or Problem · 1

    A CUSTOMER REPLACED AN (B)(4) TRANSDUCER THAT PRODUCED POOR IMAGE QUALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452352 TRANSDUCER, S8-3T MICRO TEE IYO, IYN ITX IYO PHILIPS ULTRASOUND, INC. 989605420181 B0N93V

    Patients

    Seq Age Sex Outcome Treatment
    1