BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 8478056 · Received April 3, 2019

    Report

    Report Number
    8010042-2019-00228
    Event Type
    Malfunction
    Date Received
    April 3, 2019
    Date of Event
    March 12, 2019
    Report Date
    October 30, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 PERON: (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT DURING PATIENT TREATMENT THE INSPIRATORY TIDAL VOLUME INCREASED FROM SET 450 ML TO 4000 ML AND THAT THE DEVICE GENERATED SEVERAL OTHER VENTILATOR RELATED ALARMS. OUR FIELD SERVICE ENGINEER REPORTED THAT THE CUSTOMER HAS DECIDED NOT TO REPAIR THE UNIT. THE CUSTOMER HAS TAKEN THE UNIT OUT OF SERVICE. THE EVALUATION OF RECEIVED DEVICE LOGS CONFIRMS SEVERAL OCCURRENCES OF THE REPORTED ALARMS ON THE REPORTED DATE OF EVENT. THE GENERATED ALARMS INDICATE LEAKAGE IN THE PATIENT CIRCUIT BUT ALSO CONTAIN ALARMS FOR HIGH AIRWAY PRESSURE, FOR EXAMPLE CAUSED BY KINKED OR BLOCKED TUBING. THE TRUE CAUSE OF THESE EVENTS CANNOT BE DETERMINED DUE TO LACK OF INFORMATION. THERE IS NO INDICATION OF A TECHNICAL VENTILATOR MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PATIENT TREATMENT, THE INSPIRATORY TIDAL VOLUME INCREASED FROM SET 450 ML TO 4000 ML. THERE WAS NO PATIENT HARM. (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
    273417 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1