BEUDAMED
    FDA Adverse Event Death Summary report: N

    6VT-D PROBE WITH VIVID E9

    MDR report key: 12071686 · Received June 25, 2021

    Report

    Report Number
    9610482-2021-00003
    Event Type
    Death
    Date Received
    June 25, 2021
    Date of Event
    May 27, 2021
    Report Date
    June 25, 2021
    Manufacturer
    GE VINGMED ULTRASOUND AS
    Product Code
    ITX
    PMA / PMN Number
    K141093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT EXAMINED ON (B)(6) 2021 WITH 6VT-D (SN (B)(4)) PROBE WITH VIVID E95 (SN (B)(4)) WAS EVALUATED VIA A CT THORAX EXAM POST TEE AND WAS DIAGNOSED WITH PNEUMOMEDIASTINUM (ESOPHAGEAL PERFORATION - EP), A SEVERE COMPLICATION OF TEE, AND DIED A DAY AFTER THE TEE EXAM ((B)(6) 2021). AT THE TIME THE CUSTOMER DID NOT SUSPECT ANY PROBE MALFUNCTIONS CONTRIBUTED TO THE EP. AT A LATER DATE, AND RETROSPECTIVELY, THE CUSTOMER ASKED GEHC TO EVALUATE THE 6VT-D PROBE FOR SHARP EDGES. GEHC EVALUATED THE PROBE, CONCLUDING THE 6VT-D PROBE DID NOT MALFUNCTION NOR DID IT HAVE SURFACE DEFECTS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EP. GEHC BELIEVES THAT THE EP THE PATIENT SUFFERED TO BE A SEVERE COMPLICATION OF A TEE EXAMINATION, WHICH IS A WELL-KNOWN POTENTIAL RISK OF TEE EXAMINATIONS. GEHC IS MONITORING EP AS A RESULT OF TEE FOR TRENDS. AT THIS TIME GEHC HAS NO FURTHER ACTIONS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967552 6VT-D PROBE WITH VIVID E9 ULTRASOUND TRANSDUCER ITX GE VINGMED ULTRASOUND AS 210339

    Patients

    Seq Age Sex Outcome Treatment
    1