BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSDUCER, S8-3T MICRO TEE

    MDR report key: 3000125 · Received February 14, 2013

    Report

    Report Number
    3019216-2013-00001
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Report Date
    January 18, 2013
    Manufacturer
    PHILIPS ULTRASOUND, INC.
    Product Code
    IYO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMAGE QUALITY DEGRADATION DURING CLINICAL USE OF THE S8-3T WAS REPORTED UNDER 21CFR 806 PER (B)(4). CUSTOMERS WERE INFORMED ABOUT WHAT ACTIONS TO TAKE IN ORDER TO PREVENT RISKS FOR PATIENT. THE RETURNED DEVICE WAS EVALUATED AND CONFIRMED TO BE ASSOCIATED WITH THE ISSUE IDENTIFIED IN THE RECALL. THERE HAVE BEEN NO ADVERSE EVENTS AS A RESULT OF THIS ISSUE.

    Description of Event or Problem · 1

    PHILIPS HEALTHCARE CUSTOMER SERVICE CENTER RECEIVED A CALL FROM THE CUSTOMER STATING THAT THEIR S8-3T TRANSDUCER NEEDED TO BE REPLACED BECAUSE IT WAS DAMAGED AND UNUSABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64888 TRANSDUCER, S8-3T MICRO TEE IYO IYN ITX IYO PHILIPS ULTRASOUND, INC. 989605379471 03FGP2

    Patients

    Seq Age Sex Outcome Treatment
    1