BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENGSTROM

    MDR report key: 9819557 · Received March 11, 2020

    Report

    Report Number
    2112667-2020-00694
    Event Type
    Death
    Date Received
    March 11, 2020
    Date of Event
    February 9, 2020
    Report Date
    April 20, 2020
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K041775
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER THE EVENT, A GE HEALTHCARE FIELD ENGINEER EVALUATED THE SYSTEM AND SYSTEM LOGS. A SYSTEM CHECKOUT WAS PERFORMED. THE CIRCUIT LEAK TEST FAILED. THE EXHALATION HOUSING WAS LEAKING. THE EXHALATION HOUSING WAS REPLACED. THE CHECKOUT WAS PERFORMED AGAIN AND PASSED. PER ENGINEERING RECOMMENDATION, THE VENTILATOR CONTROL BOARD (VCB) WAS REPLACED. THE ORIGINAL VCB WAS RETURNED TO GE HEALTHCARE PRODUCT ENGINEERING FOR EVALUATION. GE HEALTHCARE PRODUCT ENGINEERING PERFORMED AN INVESTIGATION OF THIS EVENT. THE RETURNED VCB WAS INSTALLED INTO ANOTHER UNIT FOR TESTING. THE VENTILATOR RAN FOR A WEEK AND THE REPORTED SHUTDOWN COULD NOT BE DUPLICATED. THE SYSTEM LOGS WERE ALSO REVIEWED, AND IT WAS CONCLUDED THAT THE DEVICE DID NOT MALFUNCTION WHILE THE PATIENT WAS ON THE VENTILATOR, BUT DID SHUT DOWN AFTER THE PATIENT WAS REMOVED FROM THE VENTILATOR. THE ROOT CAUSE OF THE REPORTED ISSUE IS UNDETERMINED BECAUSE THE ISSUE COULD NOT BE DUPLICATED. THE CUSTOMER RESPIRATORY THERAPY MANAGER STATED THAT THE PATIENT DIED A DAY OR TWO LATER BUT NOT DUE TO THE VENTILATOR ISSUE. THEREFORE, THE VENTILATOR DID NOT CAUSE HARM TO THE PATIENT OR CONTRIBUTE IN THE PATIENT'S DEATH IN THE DAYS FOLLOWING THE INCIDENT.

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. NO PATIENT INFORMATION AVAILABLE AT TIME OF FILING. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT WHILE IN USE ON A PATIENT, THE SYSTEM ALARMED AND SUBSEQUENTLY SHUT DOWN RESULTING IN A LOSS OF MECHANICAL VENTILATION. THE HOSPITAL ALSO REPORTED THAT AFTER THIS EVENT, THE PATIENT DIED FROM CAUSES NOT RELATED TO THE GE HEALTHCARE VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280187 ENGSTROM CRITICAL CARE VENTILATER CBK DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death