BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARESCAPE R860

    MDR report key: 11901196 · Received May 28, 2021

    Report

    Report Number
    2112667-2021-01364
    Event Type
    Injury
    Date Received
    May 28, 2021
    Date of Event
    May 4, 2021
    Report Date
    December 13, 2021
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K142679
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE PRODUCT ENGINEERING PERFORMED AN INVESTIGATION OF THIS EVENT. BASED ON ANALYSIS OF THE AVAILABLE INFORMATION FROM THE LOG AND COMPLAINT DATA, IT CANNOT BE DETERMINED WHETHER THE EXHALATION VALVE, THE EXHALATION FLOW SENSOR, OR THE ENTIRE EXHALATION VALVE ASSEMBLY (EVA) WAS REPLACED. THE COMPLAINT DATA STATES THE EXHALATION VALVE WAS REPLACED, WHEREAS THE LOG DOCUMENTS ERRORS RELATED TO THE EVENTS INDICATING THE FLOW SENSOR WAS REMOVED. BASED ON THE LOGS AND INPUT FROM THE COMPLAINT, THERE IS NO HARDWARE NOR SOFTWARE FAULT IDENTIFIED. COMPLETION OF THE CUSTOMER QUESTIONNAIRE WAS DECLINED, AND GE HEALTHCARE DID NOT RECEIVE THE EVA USED IN THE CASE. THE DEVICE LOGS INDICATED THE DEVICE PERFORMED AS DESIGNED, INCLUDING ALARMING APPROPRIATELY. HOWEVER, IT IS UNKNOWN HOW THE PATIENT BECAME DISCONNECTED FROM THE VENTILATOR. THE DEVICE WAS CALIBRATED SEVERAL TIMES, TESTED ON A TEST BALLOON, AND THE MALFUNCTION COULD NOT BE PRODUCED. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE CANNOT BE DETERMINED.

    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. PATIENT INFORMATION COULD NOT BE OBTAINED DUE TO COUNTRY PRIVACY LAWS. UNIQUE IDENTIFIER: (B)(4). 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 THE UNIT STOPPED VENTILATING DURING PATIENT USE. THE PATIENT DESATURATED TO 64%. THE PATIENT WAS SWITCHED TO MANUAL VENTILATION WHILE THE EXPIRATORY VALVE WAS REPLACED. ONCE THE EXPIRATORY VALVE WAS REPLACED, PATIENT WAS RECONNECTED TO THE VENTILATOR AND THE CASE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798875 CARESCAPE R860 VENTILATOR, CONTINUOUS, FACILITY USE CBK DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention