BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 7846924 · Received September 5, 2018

    Report

    Report Number
    8010042-2018-00466
    Event Type
    Malfunction
    Date Received
    September 5, 2018
    Date of Event
    August 24, 2018
    Report Date
    November 30, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERSON: (B)(4). THE VENTILATOR WAS INVESTIGATED ON SITE AND THE AIR GAS MODULE WAS REPLACED AND RETURNED FOR INVESTIGATION. THE AIR GAS MODULE REGULATES THE INSPIRATORY AIR GAS FLOW TO THE PATIENT. DURING SIMULATED USE TEST OF THE RETURNED AIR GAS MODULE IN A VENTILATOR IT FAILED WITH ¿SYSTEM VOLUME TOO LARGE¿ DURING PRE-USE CHECK. THE FAILURE WAS CAUSED BY A DEFECTIVE DELTA PRESSURE TRANSDUCER ON A PRINTED CIRCUIT BOARD INSIDE THE GAS MODULE. IF THIS FAULT HAPPENS DURING VENTILATION, IT MAY LEAD TO STOP OF VENTILATION. FLOW AND PRESSURE MAY ALSO DEVIATE FROM THE EXPECTED. ALARMS WILL BE ACTIVATED IF THE FAILURE OCCURS DURING VENTILATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR WAS SELF-CYCLING AND DID NOT RETURN ANY VOLUME. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688536 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1