BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCAVITY BIPLANE TRANSDUCER

    MDR report key: 10894129 · Received November 24, 2020

    Report

    Report Number
    10894129
    Event Type
    Malfunction
    Date Received
    November 24, 2020
    Date of Event
    November 2, 2020
    Report Date
    November 19, 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 · 0

    ULTRASOUND SCANNER 1202 NOT WORKING. THE OR SAID THERE WAS NO ERROR CODE. WHEN THE PROBE WAS ATTACHED TO THE ULTRASOUND MACHINE, THERE WAS NO IMAGE.

    Description of Event or Problem · 1

    ULTRASOUND SCANNER 1202 NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1357928 ENDOCAVITY BIPLANE TRANSDUCER TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX BK MEDICAL APS 8848

    Patients

    Seq Age Sex Outcome Treatment
    1 24820 DA