BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVID E9 4D EXPERT

    MDR report key: 2527404 · Received April 6, 2012

    Report

    Report Number
    9610482-2012-00003
    Event Type
    Malfunction
    Date Received
    April 6, 2012
    Date of Event
    March 8, 2012
    Report Date
    March 9, 2012
    Manufacturer
    GE VINGMED ULTRASOUND AS
    Product Code
    IYN
    PMA / PMN Number
    K101149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOSPITAL ENGINEER RECEIVED A SUBSTANTIAL ELECTRIC SHOCK TO HIS HAND WHEN TRIED TO RESTART THE ULTRASOUND VIVID E9 4D EXPERT SYSTEM, WHICH HAD PREVIOUSLY CAUSED THE FACILITY MAINS SUPPLY FUSE TO OPEN DUE TO AN APPARENT MALFUNCTION IN THE SCANNER'S MAINS CIRCUIT. THE ENGINEER WAS EVALUATED BY SITE MEDICAL PERSONNEL AND RECEIVED A RESTING ECG SHOWING NO ADVERSE EFFECTS. NO INJURY WAS REPORTED FROM THIS INCIDENT. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIVID E9 4D EXPERT ULTRASOUND IMAGING SYSTEM IYN GE VINGMED ULTRASOUND AS

    Patients

    Seq Age Sex Outcome Treatment
    1