BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 10448020 · Received August 25, 2020

    Report

    Report Number
    10448020
    Event Type
    Malfunction
    Date Received
    August 25, 2020
    Date of Event
    July 22, 2020
    Report Date
    August 11, 2020
    Manufacturer
    GE VINGMED ULTRASOUND AS
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE TEE PROBE FAILED THE ELECTRICAL LEAK TEST ON ONE DAY AND IT WAS NOT TAKEN OUT OF SERVICE AND USED ON ANOTHER PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913980 NA TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX GE VINGMED ULTRASOUND AS 6VT-D

    Patients

    Seq Age Sex Outcome Treatment
    1