BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-N

    MDR report key: 8178758 · Received December 19, 2018

    Report

    Report Number
    8010042-2018-00681
    Event Type
    Malfunction
    Date Received
    December 19, 2018
    Date of Event
    November 26, 2018
    Report Date
    April 9, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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 (B)(4). THE VENTILATOR WAS INVESTIGATED ON SITE AND CONTROL PRINTED CIRCUIT BOARD (PCB) WAS REPLACED AND RETURNED FOR INVESTIGATION. CONTROL PRINTED CIRCUIT BOARD (PCB) CONTROLS THE BREATHING PATTERN FOR ALL VENTILATION MODES. THE REPORTED DEVIATION WITH TWO TECHNICAL ERRORS WAS REPRODUCED DURING TEST OF THE RETURNED CONTROL PRINTED CIRCUIT BOARD (PCB). THE CONCLUSION OF THE INVESTIGATION IS THAT THE ISSUE OCCURRED, DUE TO A FAILING CPU ON THE CONTROL PCB. THE FAILURE WAS CONFIRMED IN RECEIVED DEVICE LOGS. WHY THE CENTRAL PROCESS UNIT (CPU) FAILED HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR GENERATED TWO TECHNICAL ERROR CODES, INDICATING SOFTWARE ERROR AND COMMUNICATION ERROR. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016984 SERVO-N VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1