BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 8188940 · Received December 21, 2018

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    Report

    Report Number
    8010042-2018-00686
    Event Type
    Malfunction
    Date Received
    December 21, 2018
    Date of Event
    December 13, 2018
    Report Date
    February 6, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    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). THE USER FACILITY PERFORMS SERVICE OF THEIR VENTILATORS BY THEMSELVES AND DID NOT REQUEST ANY SERVICE. IT HAS NOT BEEN COMMUNICATED IF ANY PARTS WERE REPLACED. THE EVALUATION OF PROVIDED DEVICE LOGS CONFIRMS THE REPORTED EVENT. THE LOGS SHOWED THAT THE VENTILATOR ALARMED FOR HIGH O2 CONCENTRATION ON THE REPORTED EVENT DATE. ALARMS FOR HIGH O2 CONCENTRATION ARE GENERATED WHEN THE O2 CONCENTRATION BECOMES HIGHER THAN THE UPPER ALARM LIMIT WHICH IS SET VALUE +5 VOL%. THERE ARE NO TECHNICAL ERROR CODES THAT INDICATE ANY TECHNICAL ISSUES WITH THE VENTILATOR. PRE-USE CHECKS PRIOR AND AFTER THE REPORTED EVENT WERE PASSED WITHOUT REMARKS. SINCE NO PART WAS RETURNED FOR INVESTIGATION, THE ROOT CAUSE OF THE ALARMS FOR HIGH O2 CONCENTRATION HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR ALARMED FOR HIGH O2 CONCENTRATION. PATIENT INVOLVEMENT IS UNKNOWN. (B)(4).

    Description of Event or Problem · 0

    IMPORTER REF. #: CC-CPL-2018-02055. MANUFACTURER REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028378 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1