BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 7746807 · Received August 3, 2018

    Report

    Report Number
    8010042-2018-00402
    Event Type
    Malfunction
    Date Received
    August 3, 2018
    Date of Event
    July 12, 2018
    Report Date
    September 27, 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
    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

    OUR INVESTIGATION IS FINALIZED. OUR FIELD SERVICE ENGINEER (FSE) WHO WAS ON SITE DID NOT DUPLICATE ISSUE, REGARDING THE VENTILATOR DID NOT REGISTER VOLUMES THAT WERE SET BY USER. NO PARTS WERE EXCHANGED. THE FSE DOWNLOADED THE LOGS AND THE VENTILATOR WAS PUT BACK IN SERVICE. THE EVENT DATE WAS NOT GIVEN, BUT THE MENTIONED ISSUE VERIFIED IN THE LOGS STARTING FROM 07/12/2018 AND CONTINUED ON 07/13/2018. THE CLINICAL ALARMS SUCH AS VT (TIDAL VOLUME) INSPIRATORY OVER RANGE, PEEP (POSITIVE END- EXPIRATORY PRESSURE) LOW, RESPIRATORY RATE: HIGH AND EXPIRATORY MINUTE VOLUME LOW WERE GENERATED. THESE ALARMS ARE ATTRIBUTED WHEN A LEAKAGE IS DETECTED IN THE PATIENT CIRCUIT. GAS SUPPLY PRESSURE: LOW AND APNEA ALARMS INDICATE THAT THERE WAS INSUFFICIENT VENTILATION. THE LOGS CONFIRMS THAT THE VENTILATOR PASSED PRE-USE CHECK ON 07/13/2018 AND ALSO WHEN FSE WAS ON SITE 07/19/2018. THERE ARE NO TECHNICAL ERRORS IN THE LOGS TO INDICATE THAT THERE WAS A VENTILATOR MALFUNCTION. 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

    IT WAS REPORTED THAT THE VENTILATOR DID NOT REGISTER THE VOLUMES THAT WERE SAT BY THE USER DURING PATIENT TREATMENT. 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
    588210 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1