BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVID S70N V203

    MDR report key: 14654274 · Received June 10, 2022

    Report

    Report Number
    9610482-2022-00001
    Event Type
    Malfunction
    Date Received
    June 10, 2022
    Date of Event
    April 18, 2022
    Report Date
    July 12, 2022
    Manufacturer
    GE VINGMED ULTRASOUND AS
    Product Code
    IYN
    PMA / PMN Number
    K182450
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    GEHCÂS INVESTIGATION HAS COMPLETED. ADDITIONAL INFORMATION WAS RETRIEVED FROM THE CUSTOMER TO DETERMINE THE SEQUENCE OF EVENTS AND IMPACT OF THE LOCKUP UPON PATIENT CARE. THE CUSTOMER EXPLAINED THAT A PATIENTÂS PRESSURE DROPPED DUE TO CARDIAC TAMPONADE POST-SURGERY. THE CUSTOMER NEEDED TO DRAIN THE PERICARDIUM IMMEDIATELY SO THE VIVID S70 WAS SELECTED FOR ANALYSIS & NEEDLE GUIDANCE. THE VIVID S70 WAS PUT INTO TRANSPORTATION MODE & BROUGHT TO THE PATIENT. HOWEVER, WHEN ATTEMPTING TO COME OUT OF TRANSPORTATION MODE THE VIVID S70 LOCKED UP. THE VIVID S70 HAD TO BE FORCED OFF & THEN TURNED BACK ON, AND IT TOOK APPROXIMATELY 5-7 MINUTES TO GET THE SYSTEM RUNNING NORMALLY AGAIN. DURING THIS TIME THE PATIENT WENT INTO CARDIAC ARREST AND THE DOCTOR DID NOT HAVE TIME TO WAIT FOR THE ULTRASOUND AND DID THE DRAINAGE WITHOUT THE USE OF ULTRASOUND. THE VIVID S70 WAS EVALUATED, AND IT WAS DETERMINED THAT THE CAUSE OF THE LOCKUP WHEN ATTEMPTING TO COME OUT OF TRANSPORTATION MODE WAS DUE TO EITHER AN INTERMITTENT FIRMWARE/SOFTWARE FAILURE AND/OR MIS-ALIGNED COMMUNICATION CABLE BETWEEN THE POWER SUPPLY AND CONTROLLER. THE GEHC SERVICE ENGINEER HAS RE-SEATED THE COMMUNICATION CABLE ON THE VIVID S70 AND THE ISSUE HAS NOT RECURRED. ADDITIONALLY, THE PAST THREE YEARS OF COMPLAINT FILE DATA WAS REVIEWED AND THE FREQUENCY OF OCCURRENCE OF A LOCKUP COMING OUT OF TRANSPORTATION MODE WAS DETERMINED TO BE RARE. THUS, THE RISK ASSOCIATED WITH A TEMPORARY INABILITY TO USE THE SYSTEM (A LOCKUP) HAS BEEN CONCLUDED TO BE ACCEPTABLE AND HAS BEEN REDUCED AFAP. LASTLY, A CORRECTION TO THE FIRMWARE ISSUE WAS UPDATED WITHIN FORWARD PRODUCTION DEC-2021. NO FURTHER ACTION IS NECESSARY AT THIS TIME.

    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 (B)(4). GE HEALTHCARE'S INVESTIGATION IS ON-GOING AT THIS TIME.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A PATIENT DEVELOPED TAMPONADE AND ACUTE LOSS OF BLOOD PRESSURE, AND EMERGENCY TREATMENT IS REQUIRED WHEN THIS OCCURS. THEY TRIED TO USE ULTRASOUND, PRESUMABLY AS A GUIDE FOR NEEDLE INSERTION TO DRAIN EXCESS FLUID (PERICARDIOCENTESIS), AND WHEN DOING SO THE VIVID S70N DIAGNOSTIC ULTRASOUND SYSTEM HAD BECOME UNRESPONSIVE (THE SCREEN WAS FROZEN). THEY FORCED A RESTART OF THE VIVID S70N WHICH TOOK LONGER THAN EXPECTED. MEANWHILE, THE PATIENT WENT INTO CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2195095 VIVID S70N V203 DIAGNOSTIC IMAGING ULTRASOUND IYN GE VINGMED ULTRASOUND AS NA 210315S70N

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown