BEUDAMED
    FDA Adverse Event Other Summary report: N

    STROLLER

    MDR report key: 1064608 · Received June 23, 2008

    Report

    Report Number
    3004822415-2008-00008
    Event Type
    Other
    Date Received
    June 23, 2008
    Date of Event
    July 27, 2006
    Report Date
    June 20, 2008
    Manufacturer
    CAIRE, INC.
    Product Code
    BYJ
    PMA / PMN Number
    K800742
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT NEVER RETURNED TO MFR FOR ANY INVESTIGATION AS IT WAS CONFISCATED BY FOREIGN COUNTRY, CID (POLICE). BASED ON THE INFO AND PICTURES PROVIDED BY CUSTOMER, IT WAS CONCLUDED THAT THE FIRE STARTED FROM AN EXTERNAL SOURCE. THE EXTERNAL SOURCE BURNED THE CANNULA FROM 3-4 INCHES AWAY FROM THE UNIT/OUTLET. THIS CLEARLY INDICATES THE UNIT DID NOT START FIRE ON ITS OWN AS LOX IS AN OXIDIZER AND IT REQUIRES SOURCE OF FLAME. THERE WAS NO DAMAGE INDICATED TO THE INTERIOR OF THE CAR, WHICH FURTHER INDICATES THAT THE FIRE WAS LIMITED TO THE CANNULA AT THE TIME IT WAS THROWN OUT OF THE VEHICLE. THEREFORE, AT THIS POINT, NO FURTHER INVESTIGATION WILL BE CONDUCTED BY CAIRE UNLESS OTHERWISE ADVISED BY THE FDA. NOTE: THIS INCIDENT WAS NOT REPORTED TO THE FDA IN 2006 BECAUSE IT DID NOT MEET THE REPORTING CRITERIA PER OUR UNDERSTANDING OF FDA GUIDELINES. HOWEVER, AS A RESULT OF A RECENT FDA AUDIT, WE HAVE BEEN REQUESTED TO SUBMIT THIS INCIDENT REPORT AS THE FDA AUDITOR BELIEVES THAT THIS WAS A REPORTABLE INCIDENT.

    Description of Event or Problem · 1

    STROLLER INVOLVED IN A FIRE AS PT WAS RIDING IN A VEHICLE. THE DRIVER OF THE VEHICLE STATED THAT, "A FIRE WAS SUDDENLY OCCURRED ON THE TUBE-CONNECTION OF THE STROLLER." PATIENT WAS ABLE TO STOP IMMEDIATELY, TO BREAK OFF DISCONNECT THE TUBE AND THEN TO THROW THE ALREADY PARTIALLY LIT APPARATUS FROM THE VEHICLE. NO DAMAGE TO THE VEHICLE WAS REPORTED. THE APPARATUS WAS LATER CONFISCATED BY THE POLICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STROLLER PORTABLE LIQUID OXYGEN SYSTEM BYJ CAIRE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other