BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARESCAPE R860

    MDR report key: 10105281 · Received June 1, 2020

    Report

    Report Number
    2112667-2020-01593
    Event Type
    Death
    Date Received
    June 1, 2020
    Date of Event
    May 6, 2020
    Report Date
    July 15, 2020
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K142679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM BUT FOUND THE UNIT OPERATING AS EXPECTED WITH NO ISSUES. THE SYSTEM LOGS WERE REVIEWED. AN OXYGEN SENSOR ERROR MESSAGE WAS NOTED SO THE OXYGEN SENSOR CALIBRATION WAS PERFORMED WHICH RESOLVED THE REPORTED ISSUE. THE LAST SYSTEM VERIFICATION PERFORMED BY A GE HEALTHCARE SERVICE REPRESENTATIVE WAS COMPLETED ON 21-MAR-2019. GE HEALTHCARE PRODUCT ENGINEERING INVESTIGATED THIS EVENT. THE CUSTOMER WAS UTILIZING ACTIVE HUMIDIFICATION FOR THIS PATIENT. THE USER REFERENCE MANUAL (URM) STATES THAT THE WATER TRAP SHOULD BE EMPTIED "AS NECESSARY" WHICH CAN BE DONE WHILE IN USE. THE WATER TRAP IS CLEAR AND LOCATED ON THE FRONT OF THE DEVICE FOR EASY MONITORING. THE SYSTEM LOGS INDICATE MULTIPLE DAYS OF PERSISTENT MACHINE ALARMING WHILE THE DEVICE CONTINUED TO VENTILATE. BETWEEN (B)(6) 2020 AT 10:40AM UNTIL (B)(6) 2020 AT 8:00AM THERE WERE ALARMS FOR HIGH PAW? (HIGH PATIENT AIRWAY PRESSURE) AND VT EXPIR LOW? (LOW EXPIRATORY TIDAL VOLUME) TOTALING 2,736 ALARMS OVER FOUR DAYS BEFORE THE PATIENT WAS TRANSFERRED FROM THE SYSTEM. ALARMS WERE SILENCED 15 TIMES IN THIS TIMEFRAME.

    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 REPORT OF PATIENT INVOLVEMENT. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT A PATIENT DIAGNOSED WITH COVID-19 HAD BEEN VENTILATED FOR OVER TWO WEEKS ON THIS DEVICE WHEN THE UNIT ALARMED. THE DEVICE WAS CHECKED AND FOUND TO CONTAIN WATER IN THE EXPIRATORY VALVE WATER TRAP. THE PATIENT WAS MOVED TO A DIFFERENT VENTILATOR AND PASSED AWAY SOMETIME LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567866 CARESCAPE R860 VENTILATOR, CONTINUOUS, FACILITY USE CBK DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death