BEUDAMED
    FDA Adverse Event Death Summary report: N

    IVENT 201

    MDR report key: 7390213 · Received April 2, 2018

    Report

    Report Number
    2112667-2018-00665
    Event Type
    Death
    Date Received
    April 2, 2018
    Date of Event
    March 11, 2018
    Report Date
    May 17, 2018
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K073694
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    A CHECKOUT OF THE DEVICE WAS PERFORMED BY GE HEALTHCARE. GE HEALTHCARE NOTED THAT THE BATTERY WAS EXHAUSTED AND THE DEVICE WAS NOT WORKING ON AC POWER. GE HEALTHCARE DETERMINED THAT THE FUSE WAS BLOWN, PREVENTING THE SYSTEM FROM WORKING IN AC MAINS AND CAUSING AN AC DISCONNECT ALARM. THE EXHAUSTED BATTERY WAS REPLACED WITH A CHARGED BATTERY, AND THE UNIT OPERATED ON BATTERY POWER. THE DEVICE LOGS WERE DOWNLOADED AND REVIEWED. THE LOGS INDICATE THE SYSTEM WAS USED ON BATTERY MODE FOR 54 MINUTES 39 SECONDS ON THE DATE OF THE REPORTED EVENT. ALL OF THE INDICATIONS OF AC DISCONNECT AND THE LOW BATTERY AND BATTERY EMPTY ALARMS WERE ACKNOWLEDGED BY THE USER WITHOUT TAKING THE CORRECTIVE ACTION AS INDICATED IN THE USER REFERENCE MANUAL. THE MACHINE RAN FOR 10 MINUTES AFTER THE BATTERY EMPTY ALARM WAS ACTIVATED AND THEN SHUT DOWN. THE SYSTEM SHUTDOWN OCCURRED BECAUSE THE BATTERY WAS COMPLETELY EXHAUSTED. BASED ON GE HEALTHCARE¿S OBSERVATIONS, TESTING, AND DEVICE LOG REVIEW, THE DEVICE OPERATED AS EXPECTED AND THE DEVICE SHUT DOWN DUE TO BATTERY EXHAUSTION CAUSED BY USER INACTION DESPITE ACKNOWLEDGING SYSTEM ALARMS WARNING THE USER OF THE SYSTEM CONDITIONS.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT WHILE PREPPING INTUBATED PATIENT FOR AN MRI, THE IVENT SCREEN FLASHED AND TIDAL VOLUME WAS NOT STABLE WHEN THEY PLACED THE PATIENT ON THE MRI TABLE. THE RESPIRATORY THERAPIST REPORTEDLY MADE THE DECISION TO SWITCH THE PATIENT TO AN AMBU BAG, HOWEVER, ONE WAS NOT READILY AVAILABLE. DURING RETRIEVAL OF THE AMBU BAG, THE VENTILATOR REPORTEDLY STOPPED. IT WAS REPORTED THAT THE PATIENT SUBSEQUENTLY DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232557 IVENT 201 CRITICAL CARE VENTILATER CBK DATEX-OHMEDA, INC. M1163734

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR