BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 8518867 · Received April 16, 2019

    Report

    Report Number
    8010042-2019-00264
    Event Type
    Malfunction
    Date Received
    April 16, 2019
    Date of Event
    March 26, 2019
    Report Date
    October 25, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS NOT REPRODUCED DURING ON-SITE TROUBLESHOOTING PERFORMED BY THE FIELD SERVICE ENGINEER (FSE). PERFORMED PRE-USE CHECK HAD FAILED THE O2 SENSOR TEST WITH THE MESSAGE THAT THE O2 SENSOR WAS NOT DETECTED. THE FSE REPLACED THE O2 SENSOR AND PERFORMED SEVERAL SUCCESSFUL PRE-USE CHECKS AS WELL AS FUNCTIONALITY TESTS AND CLEARED THE UNIT FOR CLINICAL USE. THE REPLACED PART WAS NOT RETURNED FOR INVESTIGATION. HOWEVER THE FAILURE OF THIS PART WOULD HAVE NOT AFFECTED ONGOING VENTILATION AS THE O2 SENSOR IS ONLY MEASURING. OUR INVESTIGATION CONSISTS OF EVALUATION OF RECEIVED DEVICE LOGS. THE LOGS WERE NOT COMPLETE AND THERE WERE NO DETAILED TEST LOGS OR TECHNICAL LOGS. THE REPORTED STOP OF VENTILATION HAS NOT BEEN CONFIRMED IN RECEIVED LOGS. THE LOGS SHOW THAT VENTILATION WAS STARTED 3 TIMES ON THE REPORTED DATE OF EVENT, FOR A FEW MINUTES OR A FEW SECONDS EACH TIME. THE LOGS SHOW THAT THE VENTILATOR WAS DELIVERING AIR AS SEVERAL ALARMS FOR HIGH PRESSURE, HIGH RESPIRATORY RATE AS WELL AS HIGH AND LOW PEEP WERE GENERATED. THE ALARMS GENERATED INDICATING A HIGH PRESSURE SITUATION LED TO LESS VENTILATION THAN INTENDED AND THIS COULD HAVE BEEN PERCEIVED AS STOP OF VENTILATION BY THE USER. THE LOGS SHOW THAT THE ALARMS HAVE BEEN SILENCED AND PARAMETERS CHANGED DURING VENTILATION INDICATING THAT THE VENTILATOR WAS UNDER SUPERVISION OF THE USER. WITH THE INFORMATION AVAILABLE WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED PROBLEM OR THE OBSERVED ALARMS IN THE LOGS.

    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

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR DID NOT VENTILATE. THERE WAS NO PATIENT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314321 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1