BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVID S70N

    MDR report key: 16108056 · Received January 5, 2023

    Report

    Report Number
    9615849-2023-00001
    Event Type
    Malfunction
    Date Received
    January 5, 2023
    Date of Event
    December 1, 2022
    Report Date
    May 19, 2023
    Manufacturer
    GE VINGMED ULTRASOUND AS
    Product Code
    IYN
    PMA / PMN Number
    K211216
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B1: ADDITIONAL INFORMATION WAS COLLECTED FROM THE CUSTOMER WHERE THEY STATED,  THE USE OF (THE VIVID S70N) DEGRADED CARE, AND,  THE PATIENT WAS IN A PRECARIOUS STATE AT THE START, AND THE OCCURRENCE OF DEATH IS MULTIFACTORIAL (ANESTHESIA, RESUSCITATION, ETC.).� THEREFORE, BOTH ADVERSE EVENT AND PRODUCT PROBLEM CHECK BOXES ARE SELECTED. B3, INCIDENT DATE: ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATED THAT THE EVENT OCCURRED ON 01-DEC-2022 AND NOT ON 06-DEC-2022 AS INITIALLY NOTIFIED TO GE HEALTHCARE (GEHC). THEREFORE, GEHC IS UPDATING THE DATE OF THE EVENT IN THIS FORM TO 01-DEC-2022. GEHC'S INVESTIGATION HAS COMPLETED. THE INVESTIGATION IDENTIFIED INTERNALLY GENERATED ELECTROMAGNETIC NOISE ON THE SYSTEM COMMUNICATION BUS (I2C) COULD INTERMITTENTLY PREVENT THE ULTRASOUND SCANNER FROM BOOTING UP, AND THIS IS LIKELY THE CAUSE OF THE DEVICE MALFUNCTION. FURTHERMORE, THE INVESTIGATION CONCLUDED THAT THE PATIENT'S SEVERE UNDERLYING MEDICAL STATUS WAS THE MAIN CONTRIBUTOR TO THE PATIENT OUTCOME. GEHC HAS INITIATED A CAPA TO FURTHER ASSESS IMPROVEMENTS TO THE ELECTROMAGNETIC COMPATIBILITY (EMC) OF THE COMMUNICATION BUS.

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION COULD NOT BE OBTAINED DUE TO COUNTRY PRIVACY LAWS. UDI: (B)(4). THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. LEGAL MANUFACTURER: HCS HAIFA U/S - NATIV HA'OR STREET NO. 1 ISRAEL HAIFA 3508510. GEHC'S INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE CUSTOMER HAS REPORTED THAT THE VIVID S70N DIAGNOSTIC ULTRASOUND SYSTEM DID NOT BOOT UP, AFTER HAVING PUT THE SYSTEM IN TRANSPORTATION MODE, SO THAT IT COULD BE USED FOR AN EMERGENCY CARDIAC CASE/PATIENT. GEHC OBTAINED ADDITIONAL INFORMATION FROM THE CUSTOMER AND MORE SPECIFICALLY THE PHYSICIAN COULD NOT UTILIZE THE VIVID S70N TO GUIDE AND CONTROL HOW THE CANNULAS FOR THE EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) DEVICE ARE PLACED INTO BLOOD VESSELS DURING A TIME-CRITICAL INTERVENTION, AND OTHER ULTRASOUND SYSTEMS WERE UNAVAILABLE AT THAT TIME. BECAUSE THE VIVID S70N WOULD NOT IMMEDIATELY BOOT UP THE PHYSICIAN ATTEMPTED INSTALLATION OF THE EMCO CANNULAS W/O ULTRASOUND GUIDANCE AND EMCO INSTALLATION WAS UNSUCCESSFUL FOR REASONS NOT SPECIFIED BY THE CUSTOMER. THE PATIENT DIED 45 MINUTES AFTER THE INTERVENTION. ADDITIONALLY, THE CUSTOMER REPORTED THE VIVID S70N TOOK MORE THAN 15 MINUTES TO BOOT UP. GEHC'S INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1644866 VIVID S70N PULSED DOPPLER ULTRASOUND IMAGINGSYS IYN GE VINGMED ULTRASOUND AS VIVID S70 V204 111162S70N

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other