BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 7487900 · Received May 4, 2018

    Report

    Report Number
    8010042-2018-00220
    Event Type
    Malfunction
    Date Received
    May 4, 2018
    Date of Event
    April 23, 2018
    Report Date
    August 8, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    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 PERSON: (B)(4).

    Additional Manufacturer Narrative · 0

    OUR DISTRIBUTOR INVESTIGATED THE VENTILATOR ON SITE. THE SOFTWARE WAS UPDATED AND THE VENTILATOR PASSED PRE-USE CHECK BUT WAS STILL QUARANTINED. OUR RECOMMENDATION WAS TO REPLACE THE CONTROL PC BOARD. THE VENTILATOR WAS THEN REPORTEDLY SCRAPPED BY THE HOSPITAL. EVALUATION OF THE DEVICE LOGS CONFIRM THE OCCURRENCE OF THE REPORTED TECHNICAL ERROR CODES DURING VENTILATION MODE, FOLLOWED BY ADDITIONAL ALARMS WHICH INDICATE THAT VENTILATION STOPPED. THE LOGS SHOW THAT THE TECHNICAL ERROR CODES WERE PRECEDED BY A BREATHING SUBSYSTEM ERROR, INDICATING AN AUTOMATIC REBOOT OF THE BREATHING SUBSYSTEM AFTER DETECTION OF AN ERROR IN THE STORED PARAMETER SETTINGS VALUES IN ITS PERSISTENT MEMORY. THIS ATTEMPTED REBOOT OF THE BREATHING SUBSYSTEM TO RECTIFY THE ERROR WAS UNSUCCESSFUL DUE TO AN INABILITY TO READ THE PERSISTENT MEMORY'S PARAMETERS. IN CONJUNCTION WITH THE UNSUCCESSFUL REBOOT ATTEMPT, THE BREATHING SUBSYSTEM COULD NOT CONNECT TO ITS PERSISTENT MEMORY WHICH HAS PARAMETER INFORMATION STORED. IN SUCH SITUATION, THE VENTILATOR WILL BY DESIGN START UP IN INFANT PATIENT CATEGORY WITH DEFAULT SETTINGS. OUR CONCLUSION IS THAT THE MOST PROBABLE CAUSE WAS A TEMPORARY CORRUPTION OF DATA OR DATA THAT WAS MOMENTARILY PERCEIVED AS CORRUPT BY THE BREATHING SUBSYSTEM AT THE TIME OF THE EVENT. AS NO PARTS WERE REPLACED AND RETURNED FOR INVESTIGATION, IT HAS NOT BEEN POSSIBLE TO DETERMINE THE TRUE ROOT CAUSE OF THE REPORTED EVENT. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE THE VENTILATOR WAS CONNECTED TO A PATIENT, IT GENERATED TWO TECHNICAL ERROR CODES. ONE INDICATED DISABLED VALVES AND THE OTHER ONE INDICATED AN INTERNAL MEMORY ERROR. THERE WAS NO PATIENT HARM. MANUFACTURER REF. #: (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331337 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1