BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCAVITY BIPLANE TRANSDUCER

    MDR report key: 10958288 · Received December 7, 2020

    Report

    Report Number
    10958288
    Event Type
    Malfunction
    Date Received
    December 7, 2020
    Date of Event
    November 2, 2020
    Report Date
    December 3, 2020
    Manufacturer
    BK MEDICAL APS
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS PREPPED AND DRAPED, AND PROCEDURE STARTED WHEN THE BRACHYTHERAPY PROBE WAS NOTED SHOWING NO IMAGE ON ULTRASOUND MACHINE AFTER REPEATED ATTEMPTS BY ROOM STAFF AND CHARGE PERSONNEL AND BIOMED TO TROUBLESHOOT UNSUCCESSFULLY. PROCEDURE WAS ABORTED. NOTE, SECOND CASE OF THE DAY THAT WAS CANCELLED. THIS SUBMISSION IS SIMILAR TO REPORT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1421540 ENDOCAVITY BIPLANE TRANSDUCER TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX BK MEDICAL APS 8848

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA