BEUDAMED
    FDA Adverse Event Death Summary report: N

    SERVO-I

    MDR report key: 5993882 · Received October 3, 2016

    Report

    Report Number
    8010042-2016-00451
    Event Type
    Death
    Date Received
    October 3, 2016
    Date of Event
    September 5, 2016
    Report Date
    September 6, 2016
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    11/15/2016 10:23 AM (GMT-5:00) ADDED BY (B)(6): NO FAULT WAS FOUND DURING ON-SITE TROUBLESHOOTING AND NO PARTS WERE REPLACED. THE INVESTIGATION COMPRISES OF EVALUATION OF THE VENTILATORS¿ LOGS AND INFORMATION THAT WAS RECEIVED. ACCORDING TO RECEIVED INFORMATION FROM DISPATCHED FSE THE PATIENT WAS BEING BAGGED WHEN THE VENTILATOR WAS IN STANDBY. NO ONE AT THE ACCOUNT WHO HE HAD SPOKEN WITH BELIEVED THAT THE VENT "PUT ITSELF INTO STANDBY" BECAUSE STANDBY IS A TWO-STEP PROCESS WHICH REQUIRES CONFIRMATION BY SELECTING "YES" ON THE TOUCHSCREEN TO END THE VENTILATION. ADDITIONAL INFORMATION FROM THE HOSPITAL STATED THAT THE PATIENT WAS IN A VERY POOR CONDITION AND CODED 5 TIMES ON THE DATE OF EVENT. IT WAS FURTHER STATED THAT THE VENTILATOR DID NOT CONTRIBUTE TO THE REPORTED PATIENT DEATH. DEVICE LOG EVALUATION SHOW THAT PERFORMED PRE-USE CHECK PRIOR TO AND AFTER THE REPORTED EVENT HAD PASSED WITHOUT DEVIATION. THERE ARE NO TECHNICAL ALARMS DURING THAT TIME. THE REPORTED PROBLEM OF THE VENTILATOR GOING TO STANDBY ON ITS OWN CANNOT BE CONFIRMED IN THE LOGS. THE LOGS SHOW THAT THE VENTILATOR WAS PUT IN STANDBY 3 TIMES DURING THE REPORTED EVENT AND ALL WERE DONE IN A CONTROLLED MANNER. THE LOGS ALSO SHOW THAT THE VENTILATOR ON THE REPORTED TIME OF DEATH (10:19 ON (B)(6) 2016) WAS STILL DELIVERING AND THE USER SET THE VENTILATOR INTO STANDBY 3 MINUTES AFTER THE REPORTED TIME OF DEATH. THE CONCLUSION IS THAT THERE WAS NO TECHNICAL VENTILATOR FAILURE. THE VENTILATOR DID NOT SET ITSELF TO STANDBY. REFERENCE EXEMPTION#: E2008006S01.

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE (B)(4).

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER STATED THAT IT WAS REPORTED TO HIM THAT THE VENT WENT INTO STANDBY ON ITS OWN WHILE ON PATIENT. I WAS TOLD THAT THE PATIENT EXPIRED. WHEN ASKED FOR ANY PATIENT INFORMATION, THE CUSTOMER SAID HE DID NOT KNOW "ASKU".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645789 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Death