BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 8297142 · Received February 1, 2019

    Report

    Report Number
    8010042-2019-00059
    Event Type
    Malfunction
    Date Received
    February 1, 2019
    Date of Event
    January 14, 2019
    Report Date
    August 16, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    THE VENTILATOR WAS INVESTIGATED ON-SITE BY OUR FIELD SERVICE ENGINEER. THE REPORTED VENTILATOR SHUTDOWN COULD NOT BE DUPLICATED AND THE VENTILATOR PASSED PRE-USE CHECKS. NO PARTS WERE REPLACED. VENTILATOR LOGS WERE DOWNLOADED. LOGS CONTAINS A SHUTDOWN NOT PRECEDED BY A CORRECT STANDBY. THERE WAS ONLY ONE LOG POST; STANDBY BUTTON ACTIVATED. (A NORMAL SHUTDOWN IN THE LOG IS PRECEDED BY ENTRIES: STANDBY BUTTON ACTIVATED, STANDBY DIALOG CONFIRMED AND STANDBY). THE VENTILATOR PASSED PRE-USE CHECK PRIOR THE REPORTED EVENT AND THE TECHNICAL LOG DOES NOT CONTAIN ANY TECHNICAL ERROR CODES CONNECTED TO THE SHUTDOWNS. A SHUTDOWN WITHOUT ANY ENTRY IN THE TECHNICAL LOG IS CONSIDERED TO BE A COMPLETE POWERING OFF OF THE VENTILATOR USING THE ON/OFF SWITCH. THIS IS CONSIDERED AS A NORMAL SHUTDOWN AND NO OTHER ALARMS ARE GENERATED. THE VENTILATOR CANNOT SHUTDOWN BY ITSELF WHEN THE ON/OFF SWITCH IS IN THE ON POSITION. THE CONCLUSION IS THAT THE SHUTDOWN OCCURRED WHILE THE ON/OFF SWITCH WAS IN THE OFF POSITION. THE CAUSE COULD HAVE BEEN TURNING OFF OF THE VENTILATOR INADVERTENTLY OR A DELAY OF THE VENTILATOR TO ATTAIN THE OFF STATE. TWO PREVENTIVE MEASURES CONSISTING OF A NEW TOGGLE SWITCH TO PREVENT INADVERTENT SWITCH OFF AND SOFTWARE MONITORING OF THE ON/OFF CIRCUITRY TO DETECT AN INACCURATE ON-OFF STATE LIKE THE DELAY IN SWITCHING OFF WERE IMPLEMENTED IN (B)(6). THE VENTILATOR IN THIS REPORT WAS MANUFACTURED BEFORE THESE MEASURES.

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERON: (B)(4).

    Description of Event or Problem · 0

    IMPORTER REF. #: (B)(4). MANUFACTURER REF. #: 1904MCC0282.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR SHUTDOWN DURING PATIENT TREATMENT. THERE WAS NO PATIENT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88828 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1