BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW-I C20

    MDR report key: 7446295 · Received April 20, 2018

    Report

    Report Number
    8010042-2018-00196
    Event Type
    Malfunction
    Date Received
    April 20, 2018
    Date of Event
    April 17, 2018
    Report Date
    June 1, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BSZ
    PMA / PMN Number
    K160665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    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 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 PERON: (B)(4). REQUESTED ADDITIONAL INFORMATION SUCH AS PERFORMED SERVICE INTERVENTION AND IF ANY PARTS NEEDED TO BE REPLACED HAS NOT BEEN RECEIVED. THE LOGS AND THE AVAILABLE INFORMATION HAVE BEEN EVALUATED AND OUR CONCLUSION WHICH IS BASED ON THE PROBLEM DESCRIPTION AND RECEIVED LOGS IS THAT THE REPORTED ISSUE WAS CAUSED BY LEAKAGES DUE TO THE PATIENT CASSETTE HAD BECOME DISLODGED FROM ITS ORIGINAL POSITION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE ON USE ON A PATIENT, THE ANESTHESIA WORKSTATION DISPLAYED VAST DIFFERENCES BETWEEN INSPIRATORY AND EXPIRATORY TIDAL VOLUMES. THERE WAS NO PATIENT HARM REPORTED. (B)(4).

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291494 FLOW-I C20 GAS-MACHINE, ANESTHESIA BSZ MAQUET CRITICAL CARE AB C20

    Patients

    Seq Age Sex Outcome Treatment
    1