BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 8416525 · Received March 13, 2019

    Report

    Report Number
    8010042-2019-00159
    Event Type
    Malfunction
    Date Received
    March 13, 2019
    Date of Event
    March 7, 2019
    Report Date
    October 31, 2019
    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 PERON: (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE VENTILATOR HAD HIGH TIDAL VOLUME ISSUES. OUR FIELD SERVICE ENGINEER WAS NOT ABLE TO DUPLICATE THE ISSUE. SEVERAL HOURS OF SIMULATED USE TEST VENTILATION WITH A TEST LUNG PASSED WITHOUT ANY ISSUES. PRE-USE CHECKS PASSED. THE VENTILATOR PASSED ALL FUNCTIONAL AND SAFETY TESTS PER FACTORY SPECIFICATIONS AND WAS RETURNED TO CUSTOMER FOR CLINICAL USE. NO FURTHER ISSUES HAVE BEEN REPORTED. THE EVALUATION OF RECEIVED DEVICE LOGS SHOWS SEVERAL OCCURRENCES OF VENTILATOR RELATED CLINICAL ALARMS ON THE DATE OF EVENT. GENERATED ALARMS MAY INDICATE LEAKAGE IN THE PATIENT CIRCUIT. THE TRUE CAUSE OF THESE EVENTS CANNOT BE DETERMINED DUE TO LACK OF INFORMATION BUT THERE WAS NO INDICATION OF A TECHNICAL VENTILATOR MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR HAD HIGH TIDAL VOLUME ISSUES. 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
    210543 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1