BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSDUCER, S8-3T MICRO TEE

    MDR report key: 3140068 · Received May 29, 2013

    Report

    Report Number
    3019216-2013-00004
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    April 30, 2013
    Manufacturer
    PHILIPS ULTRASOUND, INC.
    Product Code
    IYO
    Removal / Correction Number
    Z-2062-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRELIMINARY EVAL OF THE RETURNED S8-3T TRANSDUCER NOTES OIL SEPARATION IN THE ACOUSTIC WINDOW WHICH WAS PREVIOUSLY REPORTED UNDER 21CFR PER Z-2062-2011. FINAL EVAL OF THE RETURNED TRANSDUCER IS PENDING WHICH WILL INCLUDE AN EVAL OF THE REPORTED ARTICULATION ANOMALY. A FINAL REPORT WILL BE SUBMITTED WITH THOSE FINDINGS ONCE COMPLETED.

    Description of Event or Problem · 1

    PHILIPS HEALTHCARE CUSTOMER SERVICE CENTER RECEIVED A CALL FROM THE CUSTOMER STATING THAT THEIR S8-3T TRANSDUCER WOULD NOT CHANGE ANGLES. THE PROCEDURE COMPLETED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236438 TRANSDUCER, S8-3T MICRO TEE IYO, IYN, ITX IYO PHILIPS ULTRASOUND, INC. 989605379471 03CX6G

    Patients

    Seq Age Sex Outcome Treatment
    1