BEUDAMED
    FDA Adverse Event Death Summary report: N

    GAS MODULE 3

    MDR report key: 9901044 · Received March 30, 2020

    Report

    Report Number
    2221819-2020-00006
    Event Type
    Death
    Date Received
    March 30, 2020
    Date of Event
    February 21, 2020
    Report Date
    February 28, 2020
    Manufacturer
    SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
    Product Code
    BZK
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY REQUESTED AN EVALUATION OF THE EQUIPMENT; NO MALFUNCTION OF THE EQUIPMENT WAS CLAIMED. THE RESULTS OF THE EVALUATION DETERMINED THE GAS MODULE REQUIRED N2O CALIBRATION ONLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT MONITORED ON A PASSPORT 2 MONITOR AND GAS MODULE WAS HAVING SURGERY AND ONE MINUTE INTO THE PROCEDURE THE PATIENT'S HEART STOPPED; THE PATIENT LATER EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364590 GAS MODULE 3 GAS MODULE BZK SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Death