BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERVO-U

    MDR report key: 7548792 · Received May 29, 2018

    Report

    Report Number
    8010042-2018-00265
    Event Type
    Injury
    Date Received
    May 29, 2018
    Date of Event
    May 1, 2018
    Report Date
    November 9, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    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 BY OUR FIELD SERVICE ENGINEER. IT PASSED PRE-USE CHECK AND NO DEVICE ERRORS COULD BE DETECTED WHEN IT WAS OPERATED WITH A TEST LUNG. NO PARTS WERE REPLACED. THE VENTILATOR LOGS WERE REVIEWED. THE TECHNICAL LOG CONTAINS A RESTART OF THE PANEL SUBSYSTEM AT THE REPORTED EVENT DATE AND TIME. THE VENTILATION WILL NOT STOP IN THIS SITUATION; HOWEVER THE SCREEN WILL BE BLACK FOR A SHORT PERIOD OF TIME. THE PERFORMANCE OF THE VENTILATION PROVIDED IS NOT AFFECTED AND CONTINUES UNCHANGED. THE VENTILATOR IS DESIGNED WITH THREE SUBSYSTEMS, MONITORING AND CONTROL TOGETHER MAKING UP THE PATIENT UNIT DELIVERING BREATHS TO THE PATIENT, AND PANEL MAKING UP THE USER INTERFACE. EACH SUBSYSTEM CAN BE RESTARTED INDEPENDENTLY OF EACH OTHER AND WITHOUT INTERFERING WITH THE OPERATION OF THE OTHER TWO. NO TECHNICAL ERROR CODES WERE GENERATED DUE TO THAT THE EVENT WAS SHORTER THAN 35 SECONDS. THE CONCLUSION IS THAT THIS EVENT WAS A RESTART OF THE PANEL SUBSYSTEM AND THAT THE RESTART WAS SHORTER THAN 35 SECONDS IS BASED ON THE FINDINGS IN TECHNICAL LOG AND EVENT LOG. THE ROOT CAUSE OF THE PANEL SUBSYSTEM RESTART HAS NOT BEEN DETERMINED. 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).

    Description of Event or Problem · 0

    A FACILITY MEDWATCH WAS RECEIVED STATING: PATIENT INTUBATED AND ON VENTILATOR. WHILE RT¿S AND RN WERE IN PATIENT¿S ROOM, THEY WITNESSED THE VENTILATOR TURN OFF AND CEASE TO VENTILATE THE PATIENT. THE RT BEGAN BAGGING THE PATIENT. RT SUPERVISOR AND PICU INTENSIVIST WERE NOTIFIED AND THE VENTILATOR WAS REMOVED FROM THE PATIENT. PATIENT¿S SATURATION¿S DROPPED AND THEY NEEDED TO BE BAGGED. PATIENT WAS PLACED ON A DIFFERENT VENTILATOR AND HAS HAD NO ISSUES WITH THE VENTILATOR SINCE. MANUFACTURER REFERENCE#: (B)(4). IMPORTER REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391283 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 14 DA Life Threatening| R