BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERVO I VENTILATOR

    MDR report key: 756500 · Received August 25, 2006

    Report

    Report Number
    MW1040195
    Event Type
    Injury
    Date Received
    August 25, 2006
    Date of Event
    April 16, 2006
    Report Date
    August 25, 2006
    Manufacturer
    MAQUET INC
    Product Code
    CBK
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING PRE USE CHECK FOR SERVO I VENTILATOR, IT IS NECESSARY TO REPLACE PT CIRCUIT WITH A TESTING TUBE. DURING THE LAST PHASE OF THE PRE USE CHECK, IT IS NECESSARY TO RECONNECT THE CIRCUIT. THIS WAS NOT DONE, AND THE SERVO FINISHED THE COMPLIANCE CHECK OF THE PREUSE CHECK WITH THE TEST TUBE CONNECTED. THE PT WAS THEN ATTACHED TO THE CIRCUIT, BUT THE CIRCUIT WAS NOT ATTACHED TO THE VENTILATOR. PT REQUIRED HAND VENTIALATION UNTIL IT WAS DETERMINED WHAT WAS WRONG. WE BELIEVE THAT SOFTWARE OF THE SERVO I SHOULD BE UPDATED SO THAT THE VENTILATOR WILL DETERMINE IF THE CIRCUIT WAS ACTUALLY REPLACED. IT SHOULD DETERMINE THE COMPLIANCE OF THE TEST TUBE. IF THE COMPLIANCE IS THE SAME WHEN IT TRIES TO COMPUTE CIRCUIT COMPLIANCE, IT SHOULD KNOW THAT THE CIRCUIT WAS NOT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERVO I VENTILATOR SERVO I CBK MAQUET INC SERVO I INFANT *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening