BEUDAMED
    FDA Adverse Event Death Summary report: N

    OXYLOG 3000

    MDR report key: 3202287 · Received June 21, 2013

    Report

    Report Number
    9611500-2013-00040
    Event Type
    Death
    Date Received
    June 21, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 21, 2013
    Manufacturer
    DRAGER MEDICAL GMBH
    Product Code
    CBK
    PMA / PMN Number
    K062267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE LOG WAS ANALYZED. THE DEVICE WAS GENERATED ALARM FOR "!!! INT. BATTERY DISCHARGED". IT WAS FOUND THAT THE BATTERY WHICH HAS BEEN USED IN THE DEVICE WAS MORE THAN 6 YEARS OLD. REPLACEMENT OF THE BATTERY IN 2 YEARS INTERVALS IN PART OF REGULAR MAINTENANCE. SVC AND MAINTENANCE ARE NOT CONDUCTED BY DRAGER IN THIS CASE. THE INSTRUCTIONS FOR USE OF OXYLOG 3000 REQUIRE SUPERVISION OF VENTILATION BY QUALIFIED MEDICAL STAFF AND ALSO THAT A RESUSCITATION BAG SHALL BE AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TRANSPORT VENTILATOR OXYLOG 3000 POWERED DOWN DURING USE. ON REQUEST, THE DEVICE RECEIVED MAINTENANCE AND THE SVC ENGINEER HAS BEEN INFORMED THAT THERE WAS A PT INVOLVEMENT AND THE PT DIED. IT COULD NOT BE CLARIFIED IF THE DEVICE BEHAVIOR HAS CONTRIBUTED TO THE PT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283741 OXYLOG 3000 TRANSPORT VENTILATOR CBK DRAGER MEDICAL GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death