BEUDAMED
    FDA Adverse Event Other Summary report: N

    STROLLER G3

    MDR report key: 1064918 · Received June 25, 2008

    Report

    Report Number
    3004822415-2008-00004
    Event Type
    Other
    Date Received
    June 25, 2008
    Date of Event
    August 23, 2007
    Report Date
    May 2, 2008
    Manufacturer
    CAIRE, INC.
    Product Code
    BYJ
    PMA / PMN Number
    K800742
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER REP (2008) UNIT WILL BE RETURNED TO CAIRE FOR FURTHER INVESTIGATION. ONCE UNIT IS RETURNED, A FOLLOW UP REPORT WILL BE SUBMITTED. NOTE: THIS INCIDENT WAS NOT REPORTED TO THE FDA IN 2007 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

    PER REP, BRANCH MANAGER FOR FACILITY, "FILLED PORTABLE, GAVE IT TO PATIENT & COLD O2 WENT INTO NOSTRILLS. PATIENT SCREAMED & FLOW WAS TURNED OFF BY NURSING HOME STAFF. PATIENT GOT FROSTBITE INJURIES". "PATIENT GOT SOME BURNS. PATIENT WAS TAKEN TO HOSPITAL. PATIENT WAS RETURNED TO NURSING HOME SAME EVENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STROLLER G3 PORTABLE BYJ CAIRE, INC. 10564109

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other