BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIVID E95

    MDR report key: 17998209 · Received October 24, 2023

    Report

    Report Number
    9610482-2023-00005
    Event Type
    Death
    Date Received
    October 24, 2023
    Date of Event
    August 30, 2023
    Report Date
    August 27, 2024
    Manufacturer
    GE VINGMED ULTRASOUND AS
    Product Code
    IYN
    PMA / PMN Number
    K181685
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK A: PATIENT INFORMATION COULD NOT BE OBTAINED DUE TO COUNTRY PRIVACY LAWS. BLOCK D4, UDI: (B)(4). 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.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY.

    Additional Manufacturer Narrative · 0

    GE HEALTHCARES INVESTIGATION HAS COMPLETED. THE VIVID E95 WAS TEMPORARILY UNAVAILABLE DURING A BYPASS PROCEDURE, WHERE IT WAS USED FOR VISUALIZATION, DUE TO A NON-REPRODUCIBLE/NON-SYSTEMIC SYSTEM-LOCKUP. THE CUSTOMER RECOVERED FROM THE LOCKUP BY FORCING THE SYSTEM TO POWER DOWN AND THEN RESTARTING THE SYSTEM. IT IS INCONCLUSIVE IF THIS TEMPORARY LOSS OF VISUALIZATION RESULTED IN INCREMENTAL HARM TO THE PATIENT. 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.

    Description of Event or Problem · 0

    ON (B)(6) 2023 GE HEALTHCARE RECEIVED ADDITIONAL INFORMATION RELATED TO MANUFACTURER REPORT NUMBER 9610482-2023-00004 IN WHICH IT WAS STATED THAT THE SECOND SYSTEM WHICH FAILED TO START UP DURING A CARDIOPULMONARY BYPASS ON (B)(6) 2023 WAS IDENTIFIED AS A VIVID E95. THE CUSTOMER NOTED THE PATIENT PASSED AWAY, THEY ARE NOT ALLEGING THE VIVID E95 FAILURE TO FUNCTION CAUSED THE DEATH, AND THEY ARE DISSATISFIED WITH SYSTEM PERFORMANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1536814 VIVID E95 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM IYN GE VINGMED ULTRASOUND AS AU11128

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| D