BEUDAMED
    FDA Adverse Event Death Summary report: N

    SERVO-I

    MDR report key: 4092322 · Received September 4, 2014

    Report

    Report Number
    8010042-2014-00375
    Event Type
    Death
    Date Received
    September 4, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 7, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INTO THIS COMPLAINT CONSISTS OF DEVICE EVAL OF THE VENTILATOR'S LOGS. NO PART HAS BEEN IDENTIFIED AS FAULTY IN THE VENTILATOR SYSTEM, AND AS A CONSEQUENCE NO PART HAS BEEN EXCHANGED. THE TEST-, EVENT- AND TECHNICAL LOGS HAVE BEEN EVALUATED. THE TEST LOG CONTAINS THE RESULTS OF TESTS PERFORMED DURING THE AUTOMATED PRE-USE CHECK. THIS LOG CONTAINS A SUCCESSFUL PRE-USE CHECK PRIOR TO THE STATED VENTILATION PERIOD WAS STARTED. NO PRE-USE CHECK WAS PERFORMED AFTER THE EVENT. I.E., BEFORE THE FSE DOWNLOADING OF THE VENTILATOR'S DEVICE LOGS. THE TECHNICAL LOG CONTAINS TECHNICAL ERROR CODES AND INFO THAT WOULD INDICATE MALFUNCTION OF THE VENTILATOR. THERE ARE NO ENTRIES IN THE TECHNICAL LOG DURING THE ENTIRE VENTILATION PERIOD. THE EVENT LOG CONTAINS INFO SUCH AS OPERATOR PARAMETER SETTINGS, SET ALARM LIMITS AN GENERATED PT RELATED ALARMS E.G., PRESSURE ALARMS. ACCORDING TO RECEIVED INFO FROM HOSPITAL, THE PT WAS CONNECTED TO THE VENTILATOR FROM (B)(6). THE EVAL SHOWS THAT THE LOG CONTAINS CLINICAL ALARMS THAT ARE COMMON DURING VENTILATION TREATMENT, DURING THE GIVEN VENTILATION PERIOD. THE CONCLUSION IS THAT THERE WAS NO VENTILATOR MALFUNCTION AT THE TIME FOR THE INCIDENT. THIS FINDING IS ALSO SUPPORTED BY THE HOSPITAL'S STATEMENT THAT THEY DID NOT SUSPECT THAT THE VENTILATOR MALFUNCTIONED IN ANY WAY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT DIED WHILE BEING VENTILATED BY A VENTILATOR IN THE ICU. THE SITE REQUESTED A LOG EVAL FOR AN INTERNAL INVESTIGATION BUT STATED THAT THERE WAS NO FAULT OF THE VENTILATOR. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541457 SERVO-I CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death