BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-N

    MDR report key: 8231311 · Received January 9, 2019

    Report

    Report Number
    8010042-2019-00013
    Event Type
    Malfunction
    Date Received
    January 9, 2019
    Date of Event
    December 20, 2018
    Report Date
    May 10, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    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).

    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 PERON: (B)(4). THE VENTILATOR WAS INVESTIGATED ON SITE AND THE O2 AND THE AIR GAS MODULE WAS REPLACED AND RETURNED FOR INVESTIGATION. EVALUATION OF THE RECEIVED DEVICE LOGS SHOWS THAT THE MATCHING EVENT ON JANUARY 19 DURING THE TIME PERIOD 15:39 TO JANUARY 20 18:38. 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 ALARM FOR LOW O2 CONCENTRATION WAS CAUSED BY THE NOZZLE UNIT, THAT DID NOT PERFORMED AS EXPECTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23337 SERVO-N VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1