BEUDAMED
    FDA Adverse Event Death Summary report: N

    SERVO-I

    MDR report key: 6013750 · Received October 10, 2016

    Report

    Report Number
    8010042-2016-00457
    Event Type
    Death
    Date Received
    October 10, 2016
    Date of Event
    September 28, 2016
    Report Date
    September 29, 2016
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE NOT HAD ACCESS TO THE VENTILATOR THEREFORE IT HAS NOT BEEN INVESTIGATED. THE HOSPITAL INFORMED US THAT THEY WERE GOING TO USE AN INDEPENDENT EXPERT BUT THE RESULTS OF THIS INVESTIGATION HAVE NOT BEEN RECEIVED. OUR FIELD SERVICE ENGINEER DID NOT EXAMINE THE VENTILATOR BUT PERFORMED A PREVENTIVE MAINTENANCE (PM), 2 MONTHS AFTER THE EVENT. THERE WAS NO FAULT WITH THE VENTILATOR AND NO OTHER PARTS WERE EXCHANGED APART FROM THE PM PARTS. EVALUATION OF THE LOGS SHOWS THAT VENTILATION ON THE DAY OF THE EVENT WAS STARTED AT 05:49:58 AND WENT ON UNTIL 06:51:53 WHEN THE VENTILATOR WAS SET TO THE STANDBY MODE. PRIOR TO THE SETTING OF THE VENTILATOR INTO THE STANDBY MODE THERE WERE MANY HIGH RESPIRATORY RATE ALARMS AND THE AUDIO PAUSE FUNCTION WAS ACTIVATED 3 TIMES BY THE OPERATOR WHICH INDICATES THAT AN OPERATOR WAS PRESENT. THE AUDIO PAUSE FUNCTION TEMPORARILY SILENCES THE SOUNDING ALARMS FOR TWO MINUTES. VENTILATION WAS RESTARTED AGAIN AFTER 40 MINUTES AT 07:31:09 AND WAS SHORTLY AFTER SET TO STANDBY AGAIN. THE VENTILATOR PASSED THE PRE-USE CHECK BEFORE THE VENTILATION PERIOD AND THERE NO TECHNICAL ERROR RECORDED IN THE LOGS. WITH THE INFORMATION AVAILABLE THERE IS NOTHING THAT INDICATES THAT THERE WAS A VENTILATOR MALFUNCTION ON THE DAY OF THE EVENT. DETAILS OF THE INCIDENT HAVE NOT BEEN PROVIDED DESPITE SEVERAL ATTEMPTS TO OBTAIN THEM. THE TRUE CAUSE OF THE INCIDENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT AN INCIDENT OCCURRED WHEN THE VENTILATOR WAS CONNECTED TO A PATIENT. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT DIED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665547 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Death