BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CBK

    MDR report key: 3723728 · Received March 25, 2014

    Report

    Report Number
    8010042-2014-00108
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K062793
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTILATOR'S LOGS HAVE BEEN DOWNLOADED. A REQUEST HAS BEEN MADE FOR THE RETURN OF THE REPLACED PARTS IF ANY INVESTIGATION. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173685 CBK CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1