BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S8-3T TRANSDUCER

    MDR report key: 2852544 · Received November 15, 2012

    Report

    Report Number
    1218950-2012-03773
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 17, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IYO
    PMA / PMN Number
    K030455
    Removal / Correction Number
    Z-2062-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMAGE QUALITY DEGRADATION DURING CLINICAL USE OF THE S8-3T WAS REPORTED UNDER 21 CFR 806 PER Z-2062-2011. CUSTOMERS WERE INFORMED ABOUT WHAT ACTIONS TO TAKE IN ORDER TO PREVENT RISKS FOR PATIENTS. 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

    ACCORDING TO THE CUSTOMER, THE IMAGE RESOLUTION ON S8-3T TRANSDUCER IS NOT GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S8-3T TRANSDUCER IYO IYN ITX IYO PHILIPS MEDICAL SYSTEMS 989605379471

    Patients

    Seq Age Sex Outcome Treatment
    1