BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE

    MDR report key: 1078230 · Received July 22, 2008

    Report

    Report Number
    3004822415-2008-00009
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    May 18, 2006
    Report Date
    July 18, 2008
    Manufacturer
    CAIRE, INC
    Product Code
    BYJ
    PMA / PMN Number
    K800742
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TESTING OF THE UNIT PROVED THAT DEWAR EXPERIENCED A VACUUM LOSS. THE VACUUM LOSS OCCURED DUE TO A LEAK LOCATED AROUND THE WELD USED TO SECURE THE QDV BRACKET TO THE DEWAR'S OUTER SHELL. A FORCE OF CONSIDERABLE MAGNITUDE WHEN APPLIED TO THE DEWAR CAN CAUSE A LEAK RESULTING IN A VACUUM LOSS. THE TOP, SIDE AND BOTTOM COVERS OF THE CASE HAVE BEEN REPLACED. NOTE: A: THIS INCIDENT WAS NOT REPORTED TO THE FDA IN 2006 BECAUSE IT DID NOT MEET THE REPORTING CRITERIA PER OUR UNDERSTANDING OF THE FDA GUIDELINES. AS A RESULT OF RECENT FDA AUDIT, WE HAVE BEEN TOLD THAT THE INCIDENT WAS REPORTABLE AND CAIRE SHALL SUBMIT REPORT TO FDA. B: PURSUANT TO TITLE 21- FOOD AND DRUGS, CHAPTER 1- FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES, SUBCHAPTER H,- MEDICAL DEVICES, PART 803 - MEDICAL DEVICE REPORTING, SUBPART A - GENERAL PROVISIONS, SEC 803.16, NEITHER THIS REPORT NOR ANY INFORMATION SUBMITTED HEREIN CONSTITUTES AN ADMISSION BY CAIRE INC., OR CAIRE INC'S EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT STATED.

    Description of Event or Problem · 1

    THE STROLLER UNIT WAS FILLED 30-40 MINUTES BEFORE THE INCIDENT. PATIENT WAS IN A WHEELCHAIR AND YELLED FOR HELP. UNIT HAD FROSTED UP AND LIQUID OXYGEN HAD COME THROUGH THE CANNULA AND BURNED PATIENT. PATIENT WAS TAKEN TO HOSPITAL TO BE EXAMINED. PATIENT WAS RELEASED NEXT DAY. HE DID NOT HAVE ANY DETAILS ON PATIENT'S CONDITION. HE REFERRED US TO THE DIRECTOR OF NURSING HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTABLE FNL STROLLER T TF PB 6LPM BYJ CAIRE, INC 10564109

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization