BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 7665854 · Received July 6, 2018

    Report

    Report Number
    8010042-2018-00324
    Event Type
    Malfunction
    Date Received
    July 6, 2018
    Date of Event
    April 6, 2018
    Report Date
    September 13, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 O2 GAS MODULE WAS REPLACED AND RETURNED FOR INVESTIGATION. THE O2 GAS MODULE REGULATES THE INSPIRATORY OXYGEN GAS FLOW TO THE PATIENT. THE REPORTED FAILURE IN THE SUBTEST FLOW TRANSDUCER TEST IN PRE-USE CHECK WAS NOT REPRODUCED DURING TEST OF THE RETURNED O2 GAS MODULE IN A VENTILATOR. THE OXYGEN GAS MODULE WAS FOUND TO DELIVER MORE OXYGEN GAS THAN SPECIFICATION DURING TEST IN THE PRODUCTION TEST SYSTEM FOR GAS MODULES. THE ELECTRONICS INSIDE THE O2 GAS MODULE CAUSED THE DEVIATION. 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. ALARMS WILL BE ACTIVATED IF THE FAILURE OCCURS DURING VENTILATION. 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

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

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510243 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1