BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW-I C20

    MDR report key: 7864278 · Received September 11, 2018

    Report

    Report Number
    8010042-2018-00471
    Event Type
    Malfunction
    Date Received
    September 11, 2018
    Date of Event
    September 4, 2018
    Report Date
    February 12, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BSZ
    PMA / PMN Number
    K160665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 REFLECTOR PRESSURE TRANSDUCER PCB WAS REPLACED BY THE HOSPITAL BIOMEDICAL ENGINEER. THE REFLECTOR PRESSURE TRANSDUCER PCB WAS RETURNED FOR INVESTIGATION. TEST OF THE RETURNED PRESSURE TRANSDUCER PCB IN A REFERENCE SYSTEM COULD NOT REPRODUCE THE REPORTED FAILURE. THE SCO PASSED WITHOUT DEVIATIONS AND NO ALARMS WERE GENERATED DURING TEST IN VENTILATION MODE. EVALUATION OF THE RECEIVED DEVICE LOG SHOWS THAT THE PRESSURE TRANSDUCER TEST FAILED DUE TO THAT THE MEASURED REFLECTOR PRESSURE TRANSDUCER OFFSET BEING 0 V. THE ALLOWED OFFSET RANGE IS ± 300 MV FROM FACTORY DEFAULT OFFSET. THE FACTORY DEFAULT OFFSET FOR THE RETURNED REFLECTOR PRESSURE TRANSDUCER PCB WAS 2.045 V. THE REPORTED FAILURE CAN BE CONFIRMED IN THE DEVICE LOGS BUT IT WAS NOT REPRODUCED DURING TEST WITH THE RETURNED REFLECTOR PRESSURE TRANSDUCER PCB. OUR CONCLUSION IS THAT THE CAUSE OF THE REPORTED FAILURE WAS THE REFLECTOR PRESSURE TRANSDUCER PCB BUT THE CAUSE OF THE OFFSET FAILURE HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ANESTHESIA WORKSTATION FAILED THE PRESSURE TRANSDUCER TEST DURING SYSTEM CHECK OUT. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706519 FLOW-I C20 GAS-MACHINE, ANESTHESIA BSZ MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1