BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 8168888 · Received December 17, 2018

    Report

    Report Number
    8010042-2018-00671
    Event Type
    Malfunction
    Date Received
    December 17, 2018
    Report Date
    April 26, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERSON: (B)(4). THE REPORTED DEVICE WAS INVESTIGATED BY OUR FSE(FIELD SERVICE ENGINEER) AT THE HOSPITAL. THE DEVICE CONTROL PC (PRINTED CIRCUIT) BOARD WAS REPLACED AND SENT IN FOR INVESTIGATION. OUR INVESTIGATION OF THE RETURNED CONTROL PC BOARD DOES NOT SHOW ANY DEVIATIONS, THE PC BOARD FUNCTION IS ACCORDING SPECIFICATION. THE EVALUATION OF THE RETURNED DEVICE LOGS SHOWS A LOTS OF VENTILATION RELATED ALARMS, THE CAUSE OF THESE ALARMS ARE DUE TO THE VENTILATION SETTINGS AND A DETECTED LEAKAGE. THE TEST LOG SHOWS THAT THE SYSTEM PRE-USE USE CHECK IS NOT PERFORMED ON A REGULARLY BASIS. THE TESTS THAT HAS BEEN PERFORMED PASSES WITH SUCCESSFUL RESULTS. THE TECHNICAL LOG DOES NOT CONTAIN ANY FINDINGS THAT COULD INDICATE ON A DEVICE MALFUNCTION. OUR EVALUATION OF THE RETURNED CONTROL PC BOARD AND DEVICE LOGS CANNOT CONFIRM ANY DEVICE MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RESPIRATORY RATE WAS DOUBLING DURING PATIENT TREATMENT. THERE WAS NO PATIENT HARM. (B)(4).

    Description of Event or Problem · 0

    IMPORTER REF. #: CC-CPL-2018-01940. MANUFACTURER REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1011980 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1