BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 8260411 · Received January 18, 2019

    Report

    Report Number
    8010042-2019-00040
    Event Type
    Malfunction
    Date Received
    January 18, 2019
    Report Date
    February 11, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    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). OUR FSE (FIELD SERVICE ENGINEER) WAS ON SITE AND INVESTIGATED THE VENTILATOR. THE CONTROL PRINTED CIRCUIT BOARD (PCB) WAS FOUND FAULTY. AS A CORRECTIVE ACTION THE FSE REPLACED THE CONTROL PCB, REINSTALLED THE SOFTWARE AND PERFORMED A SUCCESSFUL FUNCTION TEST. THE VENTILATOR WAS RETURNED FOR CLINICAL USE. THE CONTROL PCB WAS NOT RETURNED FOR INVESTIGATION, THE CUSTOMER KEPT THE CONTROL PCB. EVALUATION OF THE RECEIVED DEVICE LOG CONFIRMS THE REPORTED TECHNICAL ERROR INDICATING A FAILURE WITH THE EXPIRATORY FLOW MEASURING. THE ERROR AFFECTS THE EXPIRATORY FLOW MEASURING, IT WILL HOWEVER NOT AFFECT THE VENTILATION. THE DEVICE LOG ALSO SHOWED A TECHNICAL ERROR INDICATING AN INTERNAL MEMORY ERROR ON THE CONTROL PCB. ACCORDING TO RECEIVED INFORMATION THIS ERROR OCCURRED DURING THE INVESTIGATION ON SITE. THIS TECHNICAL ERROR IS COMMON AFTER A SOFTWARE INSTALLATION. THE TRUE ROOT CAUSE CANNOT BE DETERMINED SINCE THE CONTROL PCB WAS NOT RETURNED.

    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

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR GENERATED A TECHNICAL ERROR AND HAD A SOFTWARE RELOAD ISSUE. THERE WAS NO PATIENT INVOLVEMENT. IMPORTANT REF. #: (B)(4). MANUFACTURER REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54251 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1