BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S8-3T MICRO TEE TRANSDUCER

    MDR report key: 4897922 · Received July 8, 2015

    Report

    Report Number
    3019216-2015-00038
    Event Type
    Malfunction
    Date Received
    July 8, 2015
    Report Date
    June 26, 2015
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    ITX
    PMA / PMN Number
    K030455
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ¿S8-3T IMAGE QUALITY DEGRADATION DURING CLINICAL USE AT A CRITICAL TIME WAS PREVIOUSLY EVALUATED PER HHE # US 2011-1 AND WAS DETERMINED TO BE UNACCEPTABLE. AN EMDR REPORT WILL BE SUBMITTED FOR THIS IMAGE QUALITY ISSUE. PHILIPS COULD NOT CONFIRM THE IMAGE QUALITY ISSUE; THE TRANSDUCER HAS NOT YET BEEN RETURNED FOR EVALUATION.¿

    Additional Manufacturer Narrative · 1

    CONCLUSION: THIS IMAGING PROBLEM WAS CAUSED BY OIL SEPARATION AS A RESULT OF NUMEROUS SCRATCHES ON THE WINDOW, TIP CAPS AND BEADS. THESE SCRATCHES ARE TYPICALLY CAUSED BY CUSTOMER MISHANDLING.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHILIPS FOR ASSISTANCE REPLACING A PROBE WITH POOR IMAGE QUALITY. THE RECORD NOTES THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441774 S8-3T MICRO TEE TRANSDUCER S8-3T MICRO TEE TRANSDUCER ITX PHILIPS ULTRASOUND, INC 03CX3W

    Patients

    Seq Age Sex Outcome Treatment
    1