BEUDAMED
    FDA Adverse Event Death Summary report: N

    6VT-D

    MDR report key: 19999213 · Received August 18, 2024

    Report

    Report Number
    9610482-2024-00003
    Event Type
    Death
    Date Received
    August 18, 2024
    Date of Event
    August 1, 2024
    Report Date
    September 25, 2024
    Manufacturer
    GE VINGMED ULTRASOUND AS
    Product Code
    ITX
    PMA / PMN Number
    K223832
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LEGAL MANUFACTURER: HCS HORTEN - STRANDPROMENADEN 45 NORWAY HORTEN VESTFOLD, N-3183. GE HEALTHCARE'S HAS INVESTIGATION INTO THE REPORTED EVENT HAS BEEN INITIATED AND IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE HAS INVESTIGATED THE POSSIBLE CONTRIBUTION OF A 6VT-D DIAGNOSTIC ULTRASOUND PROBE WITH VIVID S70 SYSTEM TO PATIENT INJURY AND DEATH. THE CUSTOMER PROVIDED TO GE HEALTHCARE THE 6VT-D PROBE AND THE VIVID S70 SYSTEM FOR EVALUATION. THE PROBE WAS EVALUATED FOR SAFETY AND EFFECTIVENESS, AND NO DEFECTS WERE FOUND WITH THE PROBE. THE CONSOLE LOGFILES WERE ASSESSED FOR OVERHEATING DURING THE PATIENT EXAM, AND NO INSTANCES OF THE PROBE OVERHEATING DURING THE PATIENT EXAM WERE FOUND WITHIN LOGFILES. THEREFORE, GE HEALTHCARE HAS CONCLUDED NEITHER THE PROBE NOR THE CONSOLE MALFUNCTIONED DURING THE REPORTED INCIDENT, AND NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 0

    THE CUSTOMER HAS CONTACTED GE HEALTHCARE TO INVESTIGATE DEVICE CONTRIBUTION TO AND/OR IMPACT UPON A PATIENT DEATH. CUSTOMER REPORTS THAT DURING THE EVENING AFTER AN ATRIAL FIBRILLATION ABLATION PROCEDURE, THE PATIENT WENT THROUGH A CARDIAC DECOMPENSATION, AND THE DOCTORS DIAGNOSED A STOMACH PERFORATION AND ESOPHAGUS THICKENING. ONCE THE DIAGNOSIS WAS ESTABLISHED, THE PATIENT WAS TRANSFERRED IN ICU AND INTUBATED, UNDER MECHANICAL VENTILATION, ANTIBIOTIC THERAPY, AND ENDOSCOPIC TREATMENT (PLACEMENT OF A CLIP ON AN ACTIVE BLEEDING AREA). THE SPECIALISTS THEN DECIDED ON A CONSERVATIVE APPROACH FOR THE ESOPHAGEAL PERFORATION, DIRECTING HEALING THROUGH A NASO-JEJUNAL PROBE. SURGEONS DID NOT NOTICE ANY ISSUE WITH THE TEE PROBE DURING THIS SPECIFIC PROCEDURE. CUSTOMER REPORTS THAT SEVEN DAYS AFTER THE PROCEDURE THE PATIENT DIED. THE CUSTOMER DOES NOT FAULT THE DEVICE, AND THEY ASK GE HEALTHCARE TO DEMONSTRATE THAT NEITHER PROBE NOR ECHOGRAPH COULD HAVE CAUSED THE ISSUE. GE HEALTHCARE HAS INVESTIGATION IS IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2361888 6VT-D DIAGNOSTIC ULTRASOUND TRANSDUCER ITX GE VINGMED ULTRASOUND AS KN100120

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention| D