BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW-I C20

    MDR report key: 8635583 · Received May 23, 2019

    Report

    Report Number
    8010042-2019-00334
    Event Type
    Malfunction
    Date Received
    May 23, 2019
    Date of Event
    May 3, 2019
    Report Date
    September 16, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BSZ
    PMA / PMN Number
    K160665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANESTHESIA WORKSTATION WAS INVESTIGATED BY OUR COMPANY REPRESENTATIVE AT THE HOSPITAL. IT WAS CONCLUDED THAT THE DOUBLE CHANNEL PLATE NEEDED TO BE REPLACED DUE TO A LEAKAGE FOUND DURING THE AUTOMATIC LEAKAGE TEST WHEN PERFORMING A SYSTEM CHECK OUT (SCO). THE REPLACED DOUBLE CHANNEL PLATE WAS RETURNED FOR INVESTIGATION BUT THE DEVICE LOGS WERE NOT SAVED. THE REPORTED ISSUE WITH FAILURE OF THE LEAKAGE CHECK DURING SCO HAS NOT BEEN REPRODUCED. NO DEVIATIONS OR DAMAGES HAVE BEEN NOTICED WHEN TESTING THE RETURNED DOUBLE CHANNEL PLATE. SINCE THE LOGS FROM THE EVENT WERE NOT SAVED AND THE PROBLEM WAS NOT REPRODUCED, THE REPORTED FAULT CANNOT BE CONFIRMED. WE ARE UNABLE TO DETERMINE THE TRUE CAUSE OF THE REPORTED ISSUE.

    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).

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A LEAKAGE OCCURRED WHEN A VAPORIZER WAS CONNECTED TO ONE OF THE VAPORIZER SLOTS. MANUFACTURER'S REF #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431366 FLOW-I C20 GAS-MACHINE, ANESTHESIA BSZ MAQUET CRITICAL CARE AB C20

    Patients

    Seq Age Sex Outcome Treatment
    1