BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALDUK I

    MDR report key: 2354790 · Received October 27, 2011

    Report

    Report Number
    9611500-2011-00046
    Event Type
    Other
    Date Received
    October 27, 2011
    Date of Event
    September 14, 2011
    Report Date
    October 27, 2011
    Manufacturer
    DRAEGER MEDICAL GMBH
    Product Code
    CAN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALDUK I WHICH WAS USED AS A PRESSURE REDUCER FOR AN EMERGENCY AND TRANSPORT VENTILATOR WAS SENT TO THE MFR FOR INVESTIGATION BUT WAS NOT YET RECEIVED. AFTER COMPLETION OF THE INVESTIGATION THE RESULTS WILL BE SUBMITTED WITHIN A F/U REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER CHANGING THE O2-CYLINDER OF THE PRESSURE REDUCER ALDUK I AND OPENING THE CYLINDER VALVE A FLAME APPEARED WHICH DISAPPEARED AFTER INSTANTLY CLOSING THE VALVE AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALDUK I REGULATOR, PRESSURE, GAS CYLINDER CAN DRAEGER MEDICAL GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other