BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S

    MDR report key: 7518773 · Received May 16, 2018

    Report

    Report Number
    8010042-2018-00236
    Event Type
    Malfunction
    Date Received
    May 16, 2018
    Date of Event
    April 30, 2018
    Report Date
    September 5, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE VENTILATOR WAS INVESTIGATED ON SITE AND AN O2 GAS MODULE WAS REPLACED AND RETURNED FOR INVESTIGATION. THE REPORTED FLOW TRANSDUCER TEST IN PRE-USE CHECK WAS REPRODUCED DURING TEST OF THE RETURNED GOODS IN A REFERENCE VENTILATOR. THERE WAS FOUND THAT THE OXYGEN GAS MODULE HAD A MALFUNCTION IN THE ELECTRONICS THAT ARE RESPONSIBLE FOR THE REGULATION OF OXYGEN GAS FLOW. IF THIS FAULT HAPPENS DURING VENTILATION, THE PATIENT MAY RECEIVE AN AMOUNT OF OXYGEN IN THE GAS MIXTURE THAT DEVIATE FROM THE EXPECTED. FLOW AND PRESSURE MAY ALSO DEVIATE FROM THE EXPECTED. THE FAILURE WAS CONFIRMED IN RECEIVED DEVICE LOGS. WE COULD TRACE BACK THE REPORTED PROBLEM TO (B)(6) 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 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERSON: (B)(4).

    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).

    Description of Event or Problem · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR FAILED THE FLOW TRANSDUCER TEST DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363451 SERVO-S VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1