BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSPIRATION 5I VENTILATOR SYSTEM

    MDR report key: 4619335 · Received March 18, 2015

    Report

    Report Number
    3006135941-2015-00004
    Event Type
    Death
    Date Received
    March 18, 2015
    Date of Event
    January 20, 2015
    Report Date
    March 19, 2015
    Manufacturer
    EVENT MEDICAL LTD.
    Product Code
    CBK
    PMA / PMN Number
    K130178
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT VP OF ENGINEERING RD ALONG WITH AN EVENT CLINICAL SPECIALIST VISITED THE HOSPITAL AND DISTRIBUTOR TO CONDUCT INVESTIGATION. BASED UPON THEIR INVESTIGATION, THE REPORTED INCIDENT COULD NOT BE CONFIRMED. EXAMINATION OF THE VENTILATOR INDICATED IT IS WORKING PROPERLY WITH NO IDENTIFIABLE PROBLEMS. THE EVENT/ALARM LOG HAD BEEN WRITTEN OVER DURING SUBSEQUENT USE OF THE VENTILATOR, SO NO RECORD OF THE ALARMS OR VENTILATOR CONDITION AT THE TIME OF THE ALLEGED INCIDENT COULD BE RECOVERED FOR ANALYSIS. EVENT MEDICAL DID NOT LEARN OF THE ACTUAL DATE OF THE INCIDENT UNTIL (B)(6) 2015.

    Description of Event or Problem · 1

    VENTILATOR REPORTED TO HAVE SHUT DOWN AND ALARMED WHILE IN USE ON A PATIENT. DR. AND NURSE WERE AT BEDSIDE WHEN INCIDENT OCCURRED AND BAGGED PATIENT AND EVENTUALLY PLACED PATIENT ON ANOTHER VENTILATOR. PATIENT CONDITION WORSENED AND ULTIMATELY DIED. THE HOSPITAL SUBSEQUENTLY ELECTED TO CONTINUE USING THE VENTILATOR ON OTHER PATIENTS FOLLOWING THE INCIDENT AND VENTILATOR FUNCTIONED PROPERLY WITH NO ADDITIONAL PROBLEMS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184944 INSPIRATION 5I VENTILATOR SYSTEM CBK EVENT MEDICAL LTD. 5I

    Patients

    Seq Age Sex Outcome Treatment
    1 Death