BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 7371185 · Received March 26, 2018

    Report

    Report Number
    8010042-2018-00159
    Event Type
    Malfunction
    Date Received
    March 26, 2018
    Date of Event
    March 17, 2018
    Report Date
    March 26, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    OUR FIELD SERVICE ENGINEER INVESTIGATED THE UNIT ON SITE BUT THE FAULT COULD NOT BE REPRODUCED. THE UNIT WAS CLEARED FOR CLINICAL USE. EVALUATION OF THE RECEIVED DEVICE LOGS SHOWS THAT AFTER THE START OF THE NEBULIZING PROGRAM, A SOFTWARE ERROR ALARM FOR FAILED HANDLING OF REMAINING NEBULIZING TIME WAS GENERATED FOUR TIMES IN A ROW. THIS PROMPTED AN AUTOMATIC RESTART OF THE BREATHING SUBSYSTEM TO RECTIFY THE DETECTED PROBLEM. AFTER FOUR UNSUCCESSFUL RESTARTS WITH PERSISTENT INABILITY TO HANDLE THE REMAINING NEBULIZATION TIME, THE VENTILATOR PER DESIGN GENERATED A TECHNICAL ERROR CODE INDICATING DISABLED VALVES. THE CONDITIONS CAUSING THIS PROBLEM WERE LOST WHEN THE VENTILATOR WAS REBOOTED MANUALLY. THIS INDICATES THAT THE CAUSE WAS A TEMPORARY CORRUPTION OF DATA OR DATA THAT WAS MOMENTARILY PERCEIVED AS CORRUPT BY THE BREATHING SUBSYSTEM. THE CONCLUSION IS THAT AN ERROR HAS OCCURRED IN THE BREATHING SUB-SYSTEM. THE ERROR WAS OF A TEMPORARY ART, IT WAS DETECTED BY THE SYSTEM AND APPROPRIATE ALARMS WERE GENERATED. THE CAUSE OF THE ERROR WAS A TEMPORARY CORRUPTION OF DATA. THE CAUSE OF THE CORRUPTION HAS NOT BEEN DETERMINED. 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 THE VENTILATOR ALARMED FOR STOP OF VENTILATION WHILE BEING USED ON A PATIENT. THERE WAS NO PATIENT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214718 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1