BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSHIBA

    MDR report key: 2856980 · Received December 4, 2012

    Report

    Report Number
    2020563-2012-00013
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Date of Event
    October 1, 2012
    Report Date
    November 4, 2012
    Manufacturer
    TOSHIBA MEDICAL SYSTEMS CORPORATION
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN CONCLUDED THAT CLARIFICATION TRAINING WILL BE CONDUCTED TO HIGHLIGHT THE DIFFERENCES BETWEEN COLOR DOPPLER ON THE FACILITY'S TOSHIBA EQUIPMENT AND THEIR PREVIOUS ULTRASOUND SYSTEM (NON-TOSHIBA). IN ADDITION, FURTHER CLARIFICATION WILL BE ADDED TO THE USER MANUAL DESCRIBING HOW TOSHIBA'S COLOR DOPPLER FUNCTIONS.

    Additional Manufacturer Narrative · 1

    METHOD: EVALUATION IS IN PROCESS.

    Description of Event or Problem · 1

    (B)(6) MEDICAL CENTER REPORTED THAT DURING AN ENDOVAGINAL SCAN, THE TECHNICIAN WAS ALLEGEDLY UNABLE TO SHOW COLOR DOPPLER FLOW IN THE OVARY OF A PATIENT. THE DIAGNOSIS WAS GIVEN AS OVARIAN TORSION. THE PATIENT WAS TAKEN TO SURGERY WHERE IT WAS DISCOVERED TO BE A NORMAL HEALTHY OVARY WITH NORMAL BLOOD SUPPLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOSHIBA ULTRASONIC DIAGNOSTIC TRANSDUCER ITX TOSHIBA MEDICAL SYSTEMS CORPORATION PVT-661VT

    Patients

    Seq Age Sex Outcome Treatment
    1