BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYLOG 3000+

    MDR report key: 2190571 · Received July 22, 2011

    Report

    Report Number
    9611500-2011-00022
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 14, 2011
    Report Date
    July 22, 2011
    Manufacturer
    DRAEGER MEDICAL GMBH
    Product Code
    CBK
    PMA / PMN Number
    K062267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCERNED DISPOSABLE BREATHING CIRCUIT WAS REQUESTED FOR INVESTIGATION. INVESTIGATION RESULTS WILL BE REPORTED IN A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: AFTER BEGINNING VENTILATION ON A PT WITH AN OXYLOG 3000+ USING A DISPOSABLE BREATHING CIRCUIT, THE PHYSICIAN NOTICED BY EXAMINATION OF THE PT THAT THE VENTILATION WAS NOT WORKING (NO THORAX MOVEMENT). AFTERWARDS, IT HAS BEEN NOTICED BY USERS THAT A PART OF THE PRESSURE FROM THE OXYLOG 3000+ WAS RELIEVED BY THE EXHAUST VALVE (FOR OVER PRESSURE). AFTER THE INTERVENTION IN ORDER TO IDENTIFY THE CAUSE OF THE EVENT, A NURSE OPENED THE COVER OF THE EXHAUST VALVE (FOR OVER PRESSURE) AND SAW A PLICATION/FOLD IN THE MEMBRANE WHICH LED TO LEAKAGE. ONCE THIS FOLD CORRECTED, THEY TESTED THE CIRCUIT AGAIN AND IT WORKED WELL. MANUAL RESUSCITATOR BAG WAS USED DURING THE TRANSPORT. IT WAS REPORTED THAT THE EVENT HAD NO CONSEQUENCES FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXYLOG 3000+ EMERGENCY VENTILATOR CBK DRAEGER MEDICAL GMBH NA FA009769 OR FA11064

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention