BEUDAMED
    FDA Adverse Event Other Summary report: N

    STROLLER G3

    MDR report key: 1056874 · Received April 8, 2008

    Report

    Report Number
    3004822415-2008-00003
    Event Type
    Other
    Date Received
    April 8, 2008
    Date of Event
    October 1, 2007
    Report Date
    April 7, 2008
    Manufacturer
    CAIRE INC
    Product Code
    BYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER REPORTER STATEMENT (APPENDIX 1) AND COLUMBIA ANCILLARY INCIDENT REPORT (APPENDIX 2), UNIT WAS IMMEDIATELY INSPECTED AND INCIDENT WAS NOT DUPLICATED (FOR FURTHER DETAILS SEE APPENDIX 1 & 2) UNIT WAS SHIPPED TO CAIRE INC. FACILITY FOR THOROUGH TESTING. IT WAS CONCLUDED THAT UNIT WAS DROPPED SEVERAL TIMES AND CAUSED VACUUM LOSS DUE TO A CRACK IN THE WELD (NECK TO FLANGE) - SEE APPENDIX 3 (ENGINEERING TEST REPORT). CAIRE SERVICE MANUAL PROVIDES INSTRUCTIONS TO USERS IN CASE UNIT IS DROPPED, TIPPED OVER OR UNREASONABLY ABUSED. SEE ATTACHED ONE PAGE OF SVC MANUAL (WARNING SECTION-PAGE 5 OF SERVICE MANUAL) - 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. (SEE SCANNED PAGES).

    Description of Event or Problem · 1

    ACCORDING TO TOM PEACOCK "ACCORDING TO MY KNOWLEDGE, NURSE FILL THE PORTABLE, PUT IT ON THE PT. THE PT WAS NEAR THE NURSING STATION ON THE WHEEL CHAIR. THE UNIT RUN FOR 15-20 MINUTES, PT SCREAMED. STAFF SAW THAT THE CANNULA FROZEN AND LOX SHOOTING OUT OF UNIT"

    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 85 YR Other