BEUDAMED
    FDA Adverse Event Death Summary report: N

    SERVO-I

    MDR report key: 1729559 · Received June 17, 2010

    Report

    Report Number
    8010042-2010-00124
    Event Type
    Death
    Date Received
    June 17, 2010
    Date of Event
    May 17, 2010
    Report Date
    May 19, 2010
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K062793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT A PT SUFFERED A CARDIAC ARREST. AFTER THAT OCCURRENCE, THE MEDICAL STAFF DECIDED TO CONNECT THE PT TO A VENTILATOR. A SUCCESSFUL PRE-USE CHECK WAS PERFORMED ON THE VENTILATOR AT 10:27 PM AND THE PT WAS CONNECTED TO IT USING THE VOLUME CONTROL MODE OF VENTILATION. IT IS SAID THAT AFTER CONNECTING THE PT TO THE VENTILATOR, VENTILATION WAS NOT POSSIBLE. NO GAS WAS SUPPLIED TO THE PT. THE MEDICAL STAFF THEN DECIDED TO CHANGE THE VENTILATION MODE TO THE SYNCHRONIZED INTERMITTENT MANDATORY VENTILATION (SIMV) MODE BUT STILL NO GAS WAS SUPPLIED TO THE PT. IT IS REPORTED THAT VISUAL AND AUDIBLE ALARMS WERE GENERATED DURING THE EVENT. AS THE PT HAD NOT BEEN VENTILATED BY THE VENTILATOR, THE MEDICAL STAFF DECIDED TO SET THE VENTILATOR IN THE STANDBY MODE AT 10:45 PM. MANUAL VENTILATION WAS DONE. THE PT DIED DURING THE NIGHT. (B) (4). (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERVO-I CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Death