BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 8189146 · Received December 21, 2018

    Report

    Report Number
    8010042-2018-00699
    Event Type
    Malfunction
    Date Received
    December 21, 2018
    Date of Event
    December 14, 2018
    Report Date
    May 10, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LU
    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 (B)(4). CONTACT PERSON: (B)(4). THE VENTILATOR WAS INVESTIGATED ON SITE AND THE NOZZLE UNITS WAS REPLACED AND RETURNED FOR INVESTIGATION. EVALUATION OF THE RECEIVED DEVICE LOGS SHOWS THAT THE MATCHING EVENT ON DECEMBER 14 DURING THE TIME PERIOD 10:19 TO 10:26. IF THIS CONDITION OCCURS DURING VENTILATION, THE PATIENT MAY RECEIVE AN AMOUNT OF OXYGEN IN THE GAS MIXTURE THAT DEVIATE FROM THE EXPECTED AND ALARMS WILL BE ACTIVATED TO THE CONDITION. BASED ON THE REPLACED PART AND DEVICE LOGS OUR CONCLUSION IS THAT THE FLUCTUATING O2 CONCENTRATION WAS CAUSED BY THE NOZZLE UNIT, THAT DID NOT PERFORMED AS EXPECTED.

    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

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE O2 CONCENTRATION WAS FLUCTUATING DURING PATIENT TREATMENT. THERE WAS NO PATIENT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028552 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1