BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIVID E9 BREAKTHROUGH 2013

    MDR report key: 17931484 · Received October 13, 2023

    Report

    Report Number
    9610482-2023-00004
    Event Type
    Death
    Date Received
    October 13, 2023
    Date of Event
    August 30, 2023
    Report Date
    February 22, 2024
    Manufacturer
    GE VINGMED ULTRASOUND AS
    Product Code
    IYN
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCAREÂS INVESTIGATION IS CONTINUING. INITIAL REPORTER INFORMATION, SECTION E, ADDED.

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE'S INVESTIGATION HAS COMPLETED. THE VIVID E9 LOST FUNCTIONALITY DURING A BYPASS PROCEDURE, WHERE IT WAS USED FOR VISUALIZATION, DUE TO OVERHEATING. ANOTHER SYSTEM WAS USED TO ASSIST THE BYPASS PROCEDURE VISUALIZATION, AND IT IS INCONCLUSIVE IF THIS TEMPORARY LOSS OF VISUALIZATION RESULTED IN INCREMENTAL HARM TO THE PATIENT. A GE HEALTHCARE SERVICE ENGINEER VISITED THE SITE AND DETERMINED DUST BUILDUP WITHIN THE SYSTEM & AIR FILTER FROM NOT CLEANING AS PRESCRIBED WITHIN THE USER MANUAL, CAUSED THE OVERHEATING. THE ENGINEER CLEANED THE DUST FROM THE VIVID E9 SYSTEM & FILTER AND ADVISED THE CUSTOMER TO FOLLOW REGULAR DUST CLEANING PER THE USER MANUAL. THE RISK ASSESSMENT CONCLUDED AVAILABLE MITIGATIONS ARE VERIFIED TO BE EFFECTIVE AND ARE ANTICIPATED TO REDUCE THE RISK OF THIS HAZARDOUS SITUATION AS FAR AS POSSIBLE (AFAP). NO FURTHER ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 0

    BLOCK A: PATIENT INFORMATION COULD NOT BE OBTAINED DUE TO COUNTRY PRIVACY LAWS. BLOCK D4, UDI: N/A, THE DEVICE IS PRE-COMPLIANCE. BLOCK E1: THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. LEGAL MANUFACTURER: HCS HORTEN - STRANDPROMENADEN 45 NORWAY HORTEN VESTFOLD, N-3183. GE HEALTHCARE'S INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO GE HEALTHCARE ON (B)(6) 2023 THAT THEY WERE USING A VIVID E9 DURING A CARDIOPULMONARY BYPASS ON (B)(6) 2023 WITH AN EXTREMELY CRITICAL PATIENT AND THEY WERE REQUIRING TEE INFORMATION & GUIDANCE WHEN IT SHUT DOWN ON THEM, SO THEY ATTEMPTED TO USE A SECOND SYSTEM AND THAT SYSTEM FAILED TO START UP. THE PATIENT WAS ON MAXIMAL HEMODYNAMIC AND VENTILATORY SUPPORTS WITHOUT THE ABILITY TO VISUALIZE FAILING RIGHT VENTRICULAR FUNCTION. THE CUSTOMER NOTED THE PATIENT PASSED AWAY, THEY ARE NOT ALLEGING THE VIVID E9 FAILURE TO FUNCTION CAUSED THE DEATH, AND THEY ARE DISSATISFIED WITH SYSTEM PERFORMANCE. ADDITIONALLY, THEY REPORTED THAT THE SYSTEMS INVOLVED ARE AGING (~10YRS OLD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1717462 VIVID E9 BREAKTHROUGH 2013 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM IYN GE VINGMED ULTRASOUND AS UVIV9T VE97361

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| D