BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 7499299 · Received May 9, 2018

    Report

    Report Number
    8010042-2018-00228
    Event Type
    Malfunction
    Date Received
    May 9, 2018
    Date of Event
    May 1, 2018
    Report Date
    June 19, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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

    THE VENTILATOR WAS INVESTIGATED ON SITE AND THE EXPIRATORY CHANNEL PRINTED CIRCUIT (PC) BOARD WAS REPLACED AND RETURNED FOR INVESTIGATION. THIS BOARD CONTAINS ELECTRONICS WHICH INCLUDE MICROPROCESSOR FOR CONTROL OF THE SAFETY VALVE FUNCTIONS IN THE INSPIRATORY SECTION OF THE DEVICE. THE REPORTED TECHNICAL ALARMS WERE REPRODUCED DURING SIMULATED USE TEST OF THE RETURNED EXPIRATORY CHANNEL PRINTED CIRCUIT (PC) BOARD IN A REFERENCE VENTILATOR. THE PRE-USE CHECK FAILED THE INTERNAL LEAKAGE TEST SINCE THE SAFETY VALVE IS OPEN, WHEN IT WAS EXPECTED TO BE CLOSED. THE CONCLUSION OF THE INVESTIGATION IS THAT THE ISSUE OCCURRED, DUE TO A SHORT CIRCUIT IN A CAPACITOR THAT IS PART OF THE ELECTRONICS FOR SAFETY VALVE FUNCTION. (B)(4). REF. EXEMPTION #: E2018003. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE THE VENTILATOR WAS CONNECTED TO A PATIENT, IT GENERATED TECHNICAL ERROR CODES FOR POWER ERROR AND SAFETY VALVE OPEN. THERE WAS NO PATIENT HARM. MANUFACTURER REF. #: (B)(4).

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343097 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1