BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 8270596 · Received January 23, 2019

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    Report

    Report Number
    8010042-2019-00049
    Event Type
    Malfunction
    Date Received
    January 23, 2019
    Date of Event
    January 9, 2019
    Report Date
    March 11, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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 PERON: (B)(4). THE VENTILATOR WAS INVESTIGATED ON SITE AND THE O2 GAS MODULE WAS REPLACED AND RETURNED FOR INVESTIGATION. DURING SIMULATED USE TESTING OF THE RETURNED PART IN A VENTILATOR SYSTEM, IT WAS NOT ABLE TO REPRODUCE THE REPORTED O2 CONCENTRATION LOW. UNIT TESTING OF THE GAS MODULE WE WERE ALSO PERFORMED, BUT NO DEVIATIONS WERE FOUND. THERE WAS 2 ALARMS CONFIRMED FOR O2 CONCENTRATION LOW, AT JANUARY 5 21:18 AND 21:25, THEREFORE THE DATE OF EVENT WAS DETERMINED AS (B)(6) 2018. THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED EVENTS.

    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 PERON: (B)(4).

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PATIENT TREATMENT, THE VENTILATOR GENERATED ALARMS FOR LOW O2 CONCENTRATION. THERE WAS NO PATIENT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65511 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1