BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 7357998 · Received March 21, 2018

    Report

    Report Number
    8010042-2018-00153
    Event Type
    Malfunction
    Date Received
    March 21, 2018
    Date of Event
    January 22, 2018
    Report Date
    March 21, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE VENTILATOR WAS INVESTIGATED ON SITE BY OUR FIELD SERVICE ENGINEER (FSE) AND AN AIR GAS MODULE WAS REPLACED. DURING OUR SIMULATED USE TESTING IT WAS CONCLUDED THAT THE AIR GAS MODULE WAS GENERATED MORE VOLUME THAN EXPECTED. THE CAUSE OF INCREASED VOLUMES WAS TRACED TO A DEVIATION IN AN INTEGRATED CIRCUIT IN THE ELECTRONICS INSIDE THE GAS MODULE. THE FAILURE WAS CONFIRMED IN RECEIVED DEVICE LOGS. 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 THE PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199583 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1