BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 8288452 · Received January 30, 2019

    Report

    Report Number
    8010042-2019-00054
    Event Type
    Malfunction
    Date Received
    January 30, 2019
    Date of Event
    January 4, 2019
    Report Date
    August 30, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER THE SINGLE EVENT, THE USER WAS RECOMMENDED BY OUR FIELD SERVICE ENGINEER TO REPLACE THE CONTROL PRINTED CIRCUIT BOARD BUT THE USER WON'T REPLACE IT. THE USER WILL FOLLOW UP THE UNIT. THE UNIT HAS NOT REPRODUCED THE REPORTED SYMPTOM. THE EVALUATION OF THE RECEIVED DEVICE LOGS SHOWED THAT AFTER THE START OF THE NEBULIZING PROGRAM, A SOFTWARE ERROR ALARM INDICATING FAILED HANDLING OF REMAINING NEBULIZING TIME WAS GENERATED FOUR TIMES IN A ROW. THIS PROMPTED AUTOMATIC RESTARTS OF THE BREATHING SUB-SYSTEM TO RECTIFY THE DETECTED PROBLEM AFTER EACH OF THESE SOFTWARE ERROR ALARMS. AFTER FOUR UNSUCCESSFUL RESTARTS WITH PERSISTENT INABILITY TO HANDLE THE REMAINING NEBULIZATION TIME, THE VENTILATOR PER DESIGN, SUBSEQUENTLY GENERATED A TECHNICAL ERROR CODE INDICATING DISABLED VALVES. THE CONDITIONS CAUSING THIS PROBLEM WERE LOST WHEN THE VENTILATOR, MANUALLY, WAS TURNED OFF AND ON AGAIN (REBOOTED) WHICH INDICATES THAT THE CAUSE WAS A TEMPORARY CORRUPTION OF DATA, OR DATA THAT WAS MOMENTARILY PERCEIVED AS CORRUPT, BY THE BREATHING SUB-SYSTEM AT THE TIME. IN CONJUNCTION WITH THE FOUR UNSUCCESSFUL RESTARTS ATTEMPTS, THE BREATHING SUB-SYSTEM 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.

    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 PERON: (B)(4).

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR CHANGED MODES BY ITSELF AND GENERATED TECHNICAL ERRORS DURING PATIENT TREATMENT. THERE WAS NO PATIENT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81279 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1