BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW-I C20

    MDR report key: 4152475 · Received October 6, 2014

    Report

    Report Number
    8010042-2014-00450
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Report Date
    September 9, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BSZ
    PMA / PMN Number
    K133958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL MEDWATCH REPORT WILL BE PROVIDED WHEN THE INVESTIGATION IS FINISHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE ON A PATIENT, THE ANESTHESIA MACHINE FAILED TO DELIVER FLOW TO THE PATIENT. THE PATIENT WAS REMOVED FROM THE ANESTHESIA MACHINE AND VENTILATED MANUALLY. THERE WAS NO PATIENT INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622157 FLOW-I C20 BSZ MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1