BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERV-U

    MDR report key: 8743762 · Received June 28, 2019

    Report

    Report Number
    8010042-2019-00441
    Event Type
    Injury
    Date Received
    June 28, 2019
    Date of Event
    May 28, 2019
    Report Date
    August 23, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K180098
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVALUATION IS LIMITED TO THE VENTILATION PERIOD THAT STARTED ON (B)(6) 2019 AT 5:13:09 PM AND ENDED ON (B)(6) 2019 AT 10:22:22 PM BY TURNING OFF THE VENTILATOR USING THE ON/OFF SWITCH. THE VENTILATION MODE FOR THIS VENTILATION PERIOD WAS THE SIMV (PRVC) + PS MODE OF VENTILATION. THE LOGS SHOW THAT THERE WAS NO STOP VENTILATION AT ANY TIME. THERE ARE NO TECHNICAL ALARMS THAT COULD INDICATE A FAULT. HOWEVER THE VENTILATION PERIOD CONTAINS SEVERAL PRESSURE DELIVERY RESTRICTED ALARMS AND A FEW PEEP LOW ALARMS THAT INDICATE THAT THERE MAY HAVE BEEN POOR VENTILATION TO THE PATIENT WHICH WOULD HAVE BEEN PERCEIVED AS NO VENTILATION. THE COMBINATION OF THOSE ALARMS INDICATES PRESENCE OF LEAKAGE LEADING TO LESS VOLUME TO THE PATIENT. THE LOGS ALSO SHOW THAT VENTILATION WAS CONTINUED UNTIL THE TURNING OFF OF THE VENTILATOR. NOTABLE IN THE LOGS IS THAT DURING VENTILATION FROM 7:00:22 PM TO 9:07:09 PM THERE WERE NO ALARMS WHICH IMPLY THE VENTILATOR WAS VENTILATING AS SET. THE SAME ALARM PICTURE OCCURRED AGAIN FROM 10:19 PM UNTIL TURNING OFF. THE EXCERPTS FROM THE INTERNAL AND TREND LOGS SHOW THAT THERE WAS NO STOP VENTILATION AT ANY TIME. THE ALARM PRESSURE DELIVERY RESTRICTED ALARM INDICATES THAT THE INSPIRATORY FLOW HAS REACHED ITS UPPER LIMIT WHICH RESTRICTS THE PRESSURE DELIVERY. THE REMEDY IS TO CHECK FOR LEAKAGES AND THE VENTILATOR SETTINGS. AS A CONCLUSION, THERE WAS NO VENTILATOR MALFUNCTION AT ANY TIME AND THERE WAS NO STOP OF VENTILATION. THE CAUSE WAS MOST PROBABLY LEAKAGE WHICH LED TO LESS VOLUME TO THE PATIENT. THE VENTILATOR WAS FUNCTIONING AND IT ALARMED TO ALERT THE USER OF THE SITUATION.

    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 REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE THE VENTILATOR WAS CONNECTED TO A PATIENT IT STOPPED VENTILATING THE PATIENT. IT THEN RESUMED VENTILATING BUT WAS DELIVERING LOW VOLUMES TO THE PATIENT WHICH WAS INSUFFICIENT FOR THE PATIENT AND IT AGAIN STOPPED VENTILATING. THE PATENT DESATURATED TO 7%. THE FINAL PATIENT OUTCOME IS UNKNOWN. MANUFACTURER REFERENCE#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539478 SERV-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening