BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOMATOM EMOTION

    MDR report key: 8491111 · Received April 8, 2019

    Report

    Report Number
    3004977335-2018-38471
    Event Type
    Death
    Date Received
    April 8, 2019
    Date of Event
    July 2, 2018
    Report Date
    July 5, 2018
    Manufacturer
    SIEMENS HEALTHINEERS COMPUTED TOMOGRAPHY
    Product Code
    JAK
    PMA / PMN Number
    K050297
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER OBSERVED THAT THE CRITICAL EMERGENCY PATIENT HAD ARRIVED IN VERY BAD CONDITION PRIOR TO BEING PLACED ON THE CT TABLE. THE OPERATOR THEN STATED THAT WHILE THE CRITICAL PATIENT WAS BEING POSITIONED ON THE TABLE, THE PATIENT VOMITED AND ALSO LOST DIFFERENT FLUIDS FROM OTHER PARTS OF THEIR BODY, AND THEN DIED. THE DEVICE OPERATOR STATED THAT THE PATIENT PASSED AWAY BEFORE ANY CT SCANNING WAS STARTED, SO IT WOULD APPEAR THAT THE DEVICE DID NOT MALFUNCTION DURING THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO SIEMENS THAT ON (B)(6) 2018, JUST BEFORE AN EMERGENCY PATIENT SCAN PROCEDURE WITH A SOMATOM EMOTION SYSTEM, THE PATIENT VOMITED ON THE TABLE WHILE BEING POSITIONED, AND THEN THE PATIENT DIED. THE CT DEVICE DID NOT MALFUNCTION AS THE CT DIAGNOSTICS WERE NOT EVEN USED BEFORE THE PATIENT PASSED AWAY. ACCORDING TO THE OPERATOR'S STATEMENT THE DEVICE HAD NO MALFUNCTION AT THE TIME IN QUESTION AND DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284429 SOMATOM EMOTION SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK SIEMENS HEALTHINEERS COMPUTED TOMOGRAPHY 10046789

    Patients

    Seq Age Sex Outcome Treatment
    1 Death