BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S8-3T MICRO TEE TRANSDUCER

    MDR report key: 5085354 · Received September 17, 2015

    Report

    Report Number
    3019216-2015-00049
    Event Type
    Malfunction
    Date Received
    September 17, 2015
    Report Date
    September 9, 2015
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    ITX
    PMA / PMN Number
    K030455
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 # (B)(4) 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

    THE TRANSDUCER WAS RETURNED FOR EVALUATION WHICH NOTED FLUID WAS FOUND INSIDE THE MID-HANDLES AND CONNECTOR SHELL. THE EXACT CAUSE OF THE FLUID INGRESS COULD NOT BE DETERMINED, HOWEVER, IT IS INDICATIVE OF IMPROPER CLEANING AND/OR DISINFECTING TECHNIQUES. IN (B)(6) 2013 PHILIPS IMPLEMENTED A DESIGN CHANGE TO IMPROVE THE CONNECTOR¿S ABILITY TO WITHSTAND FLUID INGRESS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED WEAK/ NO CONTINUOUS WAVE DOPPLER WITH THE S8-3T MICROMULTI TEE DURING CLINICAL USE. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614790 S8-3T MICRO TEE TRANSDUCER S8-3T MICRO TEE TRANSDUCER ITX PHILIPS ULTRASOUND, INC B0KYG7

    Patients

    Seq Age Sex Outcome Treatment
    1