BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 7540623 · Received May 24, 2018

    Report

    Report Number
    8010042-2018-00258
    Event Type
    Malfunction
    Date Received
    May 24, 2018
    Date of Event
    May 7, 2018
    Report Date
    October 12, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    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 PERSON: (B)(4).

    Additional Manufacturer Narrative · 0

    THE VENTILATOR WAS INVESTIGATED ON SITE AND THE CONTROL PRINTED CIRCUIT (PC) BOARD WAS REPLACED AND RETURNED FOR INVESTIGATION. THE CONTROL PC BOARD CONTROLS THE BREATHING PATTERNS FOR ALL DIFFERENT VENTILATION MODES. THE REPORTED FAILURE IN PRE-USE CHECK WAS REPRODUCED DURING TEST OF THE RETURNED CONTROL PC BOARD AND IN A VENTILATOR. THE DEVIATION WAS CAUSED BY AN INTERGRADED CIRCUIT (IC) THAT HAS SHORT CIRCUIT THE SIGNAL DISABLE VALVES ON THE CONTROL PC BOARD. IF THIS FAULT HAPPENS DURING VENTILATION IT WILL STOP THE VENTILATION AND OPEN ALL VALVES. ALARMS WILL BE ACTIVATED IF THE FAILURE OCCURS DURING VENTILATION. THE FAILURE WAS CONFIRMED IN RECEIVED DEVICE LOGS. WE COULD TRACE BACK THE REPORTED PROBLEM TO MAY 7, THEREFORE THE DATE OF EVENT WAS DETERMINED AS (B)(6)2018. GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #E2018003. GETINGE USA SALES, LLC (B)(4). CONTACT PERSON: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR FAILED INTERNAL LEAKAGE TEST DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385870 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1