BEUDAMED
    FDA Adverse Event Death Summary report: N

    VSCAN EXTEND DUAL PROBE

    MDR report key: 11627125 · Received April 7, 2021

    Report

    Report Number
    9610482-2021-00001
    Event Type
    Death
    Date Received
    April 7, 2021
    Date of Event
    February 13, 2021
    Report Date
    July 22, 2021
    Manufacturer
    GE VINGMED ULTRASOUND AS
    Product Code
    IYN
    PMA / PMN Number
    K180995
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    GEHC INVESTIGATION HAS COMPLETED. THE DEVICE WAS RETURNED TO GEHC FOR EVALUATION, AND GEHC WAS ABLE TO EVALUATE THE DEVICE. ADDITIONALLY, GEHC AND THE CUSTOMER WERE IN COMMUNICATION WITH ONE ANOTHER TO AID IN THE INVESTIGATION OF THE ISSUE. GEHC CONCLUSION IS THAT THE DEVICE IS WORKING AS DESIGNED, AND THE CUSTOMER HAD NOT FOLLOWED INSTRUCTIONS REGARDING REGULAR DEVICE CHARGING MAINTENANCE. THE BATTERY WAS DRAINED OF POWER WHICH CAUSED THE INABILITY OF THE DEVICE TO BOOTUP WHEN INSERTING THE BATTERY. THE CUSTOMER WAS ADVISED OF DEVICE CHARGING MAINTENANCE, AND NO FURTHER ACTIONS ARE BEING TAKEN BY GEHC AT THIS TIME.

    Additional Manufacturer Narrative · 1

    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 HORTEN - (B)(4). GE HEALTHCARE'S INVESTIGATION IS ONGOING AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE RELIABILITY OF THE VSCAN EXTEND BATTERY IS POOR. THE BATTERY RESILIENCE IS AFFECTING THE CUSTOMER'S ABILITY TO PROVIDE POINT OF CARE IMAGING. THE SITUATION THEY PROVIDED SAYS, "ATTENDED A TRAUMATIC CARDIAC ARREST FOLLOWING A STABBING. DURING THE INCIDENT WE ATTEMPTED TO USE THE ULTRASOUND TO IDENTIFY IF THE PATIENT HAD A CARDIAC TAMPONADE, HOWEVER THE UNIT HAD FAILED TO TURN ON AND THEREFORE WERE UNABLE TO IDENTIFY WHETHER THE PATIENT HAD A TAMPONADE. THE PATIENT WAS PRONOUNCED DECEASED SHORTLY AFTERWARDS." THEREFORE, GEHC UNDERSTANDS THIS TO MEAN THE CUSTOMER IS ALLEGING THE FAILURE OF THE DEVICE TO FUNCTION LIMITED AND/OR IMPEDED THE ABILITY TO PROVIDE THE PROPER POSSIBLE TREATMENT (E.G. PERICARDIOCENTESIS, THE ABILITY TO PLACE A NEEDLE USING ULTRASOUND TO GUIDE PLACEMENT INTO THE SAC THAT HOLDS WHAT IS ASSUMED TO BE THE MOST FLUID AROUND THE HEART, BASED UPON PATIENT SYMPTOMS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523201 VSCAN EXTEND DUAL PROBE DIAGNOSTIC IMAGING ULTRASOUND IYN GE VINGMED ULTRASOUND AS VSCAN EXTEND DUAL P VH263271SZ

    Patients

    Seq Age Sex Outcome Treatment
    1 Death