BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRATION VENTILATOR SYSTEM

    MDR report key: 911029 · Received August 10, 2004

    Report

    Report Number
    3004023066-2004-00001
    Event Type
    Malfunction
    Date Received
    August 10, 2004
    Manufacturer
    EVENT MEDICAL LTD
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO EVENT MEDICAL FOR EVALUATION. THE DEVICE WAS EVALUATED PRIOR TO PERFORMING ANY SYSTEM TEST OR CALIBRATIONS. A COMPLETE PERFORMANCE VERIFICATION WAS CARRIED OUT. THE REPORTED FAILURE COULD NOT BE DUPLICATED. FROM THE INFORMATION AVAILABLE, EVENT MEDICAL BELIEVES THAT NO CONCLUSION CAN BE DRAWN AND THEREFORE, NO FURTHER ACTION IS NECESSARY. THIS FILE IS DEEMED TO BE CLOSED.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED THAT THE VENTILATOR FAILED TO CYCLE WHILE ON A PATIENT, THE VENTILATOR WAS ALARMING BOTH VISUALLY AND AUDIBLY. THERE WAS NO PATIENT HARM OR CHANGE IN THERAPY REPORTED. ADDITIONALLY, A REVIEW OF THE ERROR LOG CONFIRMED THAT THE VENTILATOR ALARMED APPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSPIRATION VENTILATOR SYSTEM VENTILATOR CBK EVENT MEDICAL LTD INSPIRATION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening| R