BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S8-3T MICRO TEE TRANSDUCER

    MDR report key: 4957506 · Received July 31, 2015

    Report

    Report Number
    3019216-2015-00040
    Event Type
    Malfunction
    Date Received
    July 31, 2015
    Report Date
    July 9, 2015
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    ITX
    PMA / PMN Number
    K030455
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VALUATION ANTICIPATED FOLLOWING RETURN OF DEVICE. 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. A MEDWATCH REPORT WILL BE SUBMITTED FOR THIS IMAGE QUALITY ISSUE.¿

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE PROBE CONFIRMED THE ERROR CODE AND LACK OF IMAGE REPORTED BY THE CUSTOMER. THE DEVICE WAS RETURNED WITH DAMAGE TO THE SHAFT WHICH ALLOWED FLUID INGRESS CAUSING CORROSION INSIDE THE PROBE. FINAL CONCLUSION VERIFIED THE DAMAGE WOULD CAUSE THE SYSTEM ERROR AND LOSS OF IMAGE. THE EXACT CAUSE OF THE DAMAGE COULD NOT BE DETERMINED BUT IS CONSISTENT WITH CUSTOMER MISHANDLING.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHILIPS FOR ASSISTANCE WITH AN S8-3T MODEL PROBE CAUSING AN ERROR CODE AND NOT PRODUCING AN IMAGE. DUE TO THIS EVENT INVOLVING AN S8-3T TRANSDUCER IMAGE ISSUE DURING CLINICAL USE E-MDR A REPORT WILL BE SUBMITTED TO THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501683 S8-3T MICRO TEE TRANSDUCER S8-3T MICRO TEE TRANSDUCER ITX PHILIPS ULTRASOUND, INC B131TN

    Patients

    Seq Age Sex Outcome Treatment
    1