BEUDAMED
    FDA Adverse Event Other Summary report: N

    OXYLOG 2000

    MDR report key: 1724366 · Received June 11, 2010

    Report

    Report Number
    9611500-2010-00024
    Event Type
    Other
    Date Received
    June 11, 2010
    Date of Event
    April 16, 2010
    Report Date
    June 2, 2010
    Manufacturer
    DRAEGER MEDICAL AG & CO. KG
    Product Code
    CBK
    PMA / PMN Number
    K943531
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT IS STILL UNDER INVESTIGATION OF THE (B)(6); BURNED PARTS OF THE DEVICE AND AMBULANCE CAR HAVE BEEN QUARANTINED. DURING AN ON-SITE MEETING AND INVESTIGATION WITH WITNESSES, USERS, POLICE AND DEVICE EXPERTS, NO ROOT-CAUSE OR CAUSAL CHAIN OF THE FIRE COULD BE IDENTIFIED. THE EVENT IS STILL UNDER INVESTIGATION BUT OXYGEN MUST BE ASSUMED AS A CONTRIBUTING FACTOR OF THE FIRE. RESULTS OF INVESTIGATION WILL BE REPORTED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IN A USER FACILITY REPORT IT WAS REPORTED THAT DURING AN EMERGENCY TRANSPORT IN AN AMBULANCE CAR, THE TRANSPORT VENTILATOR FELL FROM ITS FIXATION ON THE WALL. THE VENTILATOR WAS NOT IN USE. AFTER THE TRANSPORT, THE DEVICE WAS CHECKED AND THE USER NOTED THAT WHILE CONNECTING THE DEVICE TO EXTERNAL POWER SUPPLY, THE ACOUSTICAL AND OPTICAL SIGNALS OF THE DEVICE FAILED TO APPEAR. THE USER ASSUMED AN ELECTRICAL PROBLEM OF POWER SUPPLY OF THE AMBULANCE CAR AND CHECKED THE FUSES BEHIND DRIVER SEAT. SUDDENLY, HE NOTED UPCOMING FLAMES AND SMOKE BESIDE THE TRANSPORT VENTILATOR. EVEN WHILE TRYING TO EXTINGUISH THE FIRE WITH A 6KG POWDER FIRE EXTINGUISHER, THE AMBULANCE CAR AND ENVIRONMENT OF THE AMBULANCE STATION BURNED OUT. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXYLOG 2000 TRANSPORT VENTILATOR CBK DRAEGER MEDICAL AG & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other