BEUDAMED
    FDA Adverse Event Death Summary report: N

    SERVO-I

    MDR report key: 8005741 · Received October 25, 2018

    Report

    Report Number
    8010042-2018-00569
    Event Type
    Death
    Date Received
    October 25, 2018
    Date of Event
    October 1, 2018
    Report Date
    February 8, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MAQUET MEDICAL SYSTEMS USA (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MCC) (MANUFACTURER) REFERENCE EXEMPTION #: E2008006S01 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).

    Additional Manufacturer Narrative · 0

    CORRECTION TO EXEMPTION STATEMENT. EXEMPTION STATEMENT SHOULD READ AS FOLLOWS: 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).

    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). NO PARTS WERE REPLACED THEREFORE THE INVESTIGATION CONSIST OF EVALUATION OF THE INFORMATION THAT WAS RECEIVED FROM THE FACILITY AND THE VENTILATOR¿S LOGS THAT WERE RECEIVED. THE FACILITY PERFORMS OWN SERVICE THEREFORE IN-HOUSE BIOMED EXAMINED AND TESTED THE VENTILATOR AFTER THE EVENT. THE BIOMED FOUND NO FAULT AND NO PARTS WERE REPLACED. THE VENTILATOR WAS PUT BACK IN SERVICE. THE VENTILATOR¿S LOGS THAT WERE RECEIVED WERE INCOMPLETE. THE FIRST 9 HOURS OF THE DAY OF THE EVENT WERE MISSING BUT THE EVALUATION FOR THE REST OF THE DAY SHOWED THAT THE LOG CONTAINED 4 STANDBYS. ALL THE STANDBYS ARE PRECEDED BY A LOGGED ¿STANDBY BUTTON ACTIVATED¿ WHICH IMPLIES PRESSING THE STANDBY KEY BY THE USER, FOLLOWED BY A LOGGED ¿STANDBY DIALOG CONFIRMED¿ WHICH IMPLIES PRESSING THE OPTION ¿YES¿ IN THE POP-UP WINDOW WHERE AFTER THE VENTILATOR IS SET TO THE STANDBY MODE. THE TIME OF THE EVENT WAS NOT PROVIDED THEREFORE IT IS UNKNOWN WHETHER ANY OF THESE STANDBYS REPRESENTED THE ALLEGED EVENT. THE CONCLUSION IN THE MATTER IS THAT THERE IS NO INDICATION IN THE AVAILABLE INFORMATION THAT THE VENTILATOR SET ITSELF TO THE STANDBY MODE FROM VENTILATION AT ANY TIME. THE STANDBYS FROM VENTILATION ON THE DATE OF THE EVENT WERE DONE AS PER DESIGN USING THE TWO STEPS OF SETTING THE VENTILATOR TO THE STANDBY MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR WENT INTO THE STANDBY MODE WHILE IT WAS CONNECTED TO A PATIENT. THE PATIENT DIED. (B)(4).

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847140 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Death