BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 7771819 · Received August 10, 2018

    Report

    Report Number
    8010042-2018-00414
    Event Type
    Malfunction
    Date Received
    August 10, 2018
    Date of Event
    August 7, 2018
    Report Date
    September 25, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    OUR INVESTIGATION FOR THE COMPLAINT IS FINALIZED. OUR FSE (FIELD SERVICE ENGINEER) INVESTIGATED THE DEVICE ON SITE AND REPRODUCED THE REPORTED TECHNICAL ERRORS INDICATING SOFTWARE ERROR, DISABLED VALVES, COMMUNICATION ERROR AND INTERNAL MEMORY ERROR. AS RECOMMENDED IN THE SERVICE MANUAL, THE CONTROL PRINTED CIRCUIT BOARD WAS REPLACED AND THE PROBLEM WAS SOLVED. THE DEVICE RETURNED TO CLINICAL USE. WE HAVE NOT RECEIVED ANY PARTS FOR OUR INVESTIGATION. BASED ON PRIOR INVESTIGATIONS; IT APPEARS THAT AN ERROR OCCURS WHICH PUTS THE CONTROL PRINTED CIRCUIT BOARD SOFTWARE IN A STATE THAT CAUSES COMMUNICATION PROBLEMS AND STOP OF VENTILATION, WHICH THE SYSTEM IS UNABLE TO RECOVER FROM BY ITSELF. THE ROOT CAUSE OF THIS FAILURE HAS NOT BEEN DETERMINED DUE TO LACK OF GOODS AND FULL LOGS. 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)(4).

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR ALARMED FOR DISABLED VALVES AS WELL AS PATIENT CATEGORY MISMATCH BETWEEN BREATHING AND MONITORING SUBSYSTEMS. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612678 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1