BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTSTAR OXYLOG 2000

    MDR report key: 4232250 · Received April 9, 2014

    Report

    Report Number
    9611500-2014-00031
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Date of Event
    March 7, 2014
    Report Date
    April 8, 2014
    Manufacturer
    DRAEGER MEDICAL GMBH
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING, RESULTS WILL BE PROVIDED IN A F/U REPORT.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT UPON STARTING TO VENTILATE A PT 2 LOOSE FRAGMENTS OF PLASTIC HAVE BEEN FOUND IN THE BREATHING CIRCUIT. NO PT CONSEQUENCES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214018 VENTSTAR OXYLOG 2000 BREATHING CIRCUIT, DISPOSABLE CBK DRAEGER MEDICAL GMBH 331172.05

    Patients

    Seq Age Sex Outcome Treatment
    1