BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6VT-D PROBE

    MDR report key: 4001739 · Received June 30, 2014

    Report

    Report Number
    9610482-2014-00001
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    GE VINGMED ULTRASOUND AS
    Product Code
    IYO
    PMA / PMN Number
    K131514
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. UNDER EUROPEAN LAW, PT INFO IS CONSIDERED CONFIDENTIAL AND WILL NOT BE RELEASED BY THE HOSP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CARDIOPULMONARY BYPASS SURGERY WAS BEING PERFORMED AND THE 6VT-D PROBE BEING USED IN CONJUNCTION WITH A VIVID E9 FOR DIAGNOSTIC IMAGING PURPOSES FAILED TO FUNCTION WHILE THE SURGEON WAS WORKING ON THE POSTERIOR MITRAL LEAFLET. THERE WAS AN ALLEGATION FROM THE HOSP THAT THE PROBE FAILURE REQUIRED THE PROBE TO BE REMOVED AND ANOTHER TE PROBE INTUBATION DURING NEW HLM-WEANING WHEN THE PT WAS VASOPLEG AND THEY WERE INCREASING KATECHOLAMINE. NO SERIOUS INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381364 6VT-D PROBE DIAGNOSTIC ULTRASOUND TRANSDUCER, IYO, ITX, IYN IYO GE VINGMED ULTRASOUND AS

    Patients

    Seq Age Sex Outcome Treatment
    1