BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXYLOG 2000

    MDR report key: 2202274 · Received July 29, 2011

    Report

    Report Number
    9611500-2011-00023
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 25, 2011
    Manufacturer
    DRAGER MEDICAL GMBH
    Product Code
    CBK
    PMA / PMN Number
    K943531
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BREATHING SYSTEM WAS REQUESTED FOR INVESTIGATION BUT HAS NOT BEEN RETURNED YET. RESULTS OF THE INVESTIGATION WILL BE REPORTED IN A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: AFTER CONNECTION TO THE OXYLOG 2000, THE PT MADE A CARDIOVASCULAR STOP. THE PT HAD TO BE REANIMATED AND THEN THE PT WAS RESCUED. AFTER INSPECTION OF THE BREATHING CIRCUIT, IT HAS BEEN NOTICED THAT THE RED RUBBER DISC WAS PARTIALLY DISLODGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXYLOG 2000 TRANSPORT VENTILATOR CBK DRAGER MEDICAL GMBH 8412001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention