BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 8185543 · Received December 20, 2018

    Report

    Report Number
    8010042-2018-00691
    Event Type
    Malfunction
    Date Received
    December 20, 2018
    Date of Event
    December 13, 2018
    Report Date
    April 15, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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

    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)(6). THE CUSTOMER DID NOT REQUEST ANY SERVICE. 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. THE CONCLUSION IS THAT A PROBLEM OCCURRED WITH THE BREATHING SUB-SYSTEM. IT WAS DETECTED BY THE SYSTEM AND ALARMS WERE GENERATED. THE CAUSE WAS A TEMPORARY CORRUPTION OF DATA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR ALARMED FOR TWO TECHNICAL ERROR CODES, INDICATING DISABLED VALVES AND INTERNAL MEMORY ERROR. THERE WAS NO PATIENT HARM. (B)(4).

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023496 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1