BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S8-3T MICRO TEE TRANSDUCER

    MDR report key: 4957835 · Received July 31, 2015

    Report

    Report Number
    3019216-2015-00042
    Event Type
    Malfunction
    Date Received
    July 31, 2015
    Report Date
    June 15, 2015
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    ITX
    PMA / PMN Number
    K030455
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE PROBE CONFIRMED THE 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 LOSS OF IMAGE. THE CAUSE OF THE DAMAGE IS CONSISTENT WITH CUSTOMER MISHANDLING.

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, THE S8-3T TRANSDUCER HAS NOT YET BEEN RECEIVED FOR FURTHER EVALUATION. ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE DEVICE IS RETURNED AND EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    FOLLOWUP TRANSMISSION TEST ISSUE REQUEST IT.

    Description of Event or Problem · 1

    S8-3T IMAGE QUALITY DEGRADATION DURING CLINICAL USE WAS DETERMINED TO BE UNACCEPTABLE. A MEDWATCH REPORT WILL BE SUBMITTED FOR THIS IMAGE QUALITY ISSUE. NO PATIENT INJURY RESULTED.

    Description of Event or Problem · 1

    S8-3T IMAGE QUALITY DEGRADATION DURING CLINICAL USE AT A CRITICAL TIME WAS PREVIOUSLY EVALUATED PER (B)(4) AND WAS DETERMINED TO BE UNACCEPTABLE. A MEDWATCH REPORT WILL BE SUBMITTED FOR THIS IMAGE QUALITY ISSUE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502362 S8-3T MICRO TEE TRANSDUCER S8-3T MICRO TEE TRANSDUCER ITX PHILIPS ULTRASOUND, INC B11YQX

    Patients

    Seq Age Sex Outcome Treatment
    1