BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STROLLER

    MDR report key: 12093471 · Received June 30, 2021

    Report

    Report Number
    3004972304-2021-00016
    Event Type
    Injury
    Date Received
    June 30, 2021
    Date of Event
    June 16, 2021
    Report Date
    August 27, 2021
    Manufacturer
    CAIRE INC.
    Product Code
    BYJ
    PMA / PMN Number
    K800742
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PURSUANT TO TITLE 21 - FOOD AND DRUGS, CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES, SUBCHAPTER H -0 MEDICAL DEVICE, PART 803 - MEDICAL DEVICE REPORTING, SUBPART A - GENERAL PROVISIONS, SECTION 803.16, NEITHER THIS REPORT NOR ANY INFORMATION SUBMITTED HEREIN CONSTITUTES AN ADMISSION BY CAIRE INC. THAT THE DEVICE STATED IN THIS REPORT, CAIRE INC., OR CAIRE INC.'S EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT STATED HEREIN. THE DEVICE WAS RETURNED TO CAIRE FOR AN EVALUATION. WITH THE EXCEPTION A QDV LIP SEAL LEAK, THE STROLLER LIQUID OXYGEN PORTABLE TEST UNIT MET ITS FUNCTIONAL SPECIFICATIONS. ADDITIONALLY, THE TEST UNIT SHOWED NO SIGNS OF FIRE DAMAGE. THE ADVERSE EVENT FORM STATES THAT THE PATIENT, ACTIVELY USING THE TEST UNIT AT THE TIME, CAUGHT THE CANNULA ON FIRE WHILE SMOKING. BASED ON THE DESCRIPTION OF THE INCIDENT AND THE LACK OF FIRE DAMAGE TO THE TEST UNIT, IT INDICATES THAT THE FIRE ORIGINATED AT THE CANNULA AND IT DID NOT REACH THE TEST UNIT.

    Additional Manufacturer Narrative · 1

    CAIRE IS ATTEMPTING TO HAVE THE UNIT RETURNED FOR AN EVALUATION. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PATIENT SUFFERED AN INJURY WHILE USING A LOX PRODUCT. ACCORDING TO THE CARE HOME, THE PATIENT IS A SMOKER AND WAS ON THE BALCONY OF THE BUILDING WITH WHISKEY AND A CIGARETTE WHEN THE NASAL CANNULA CAUGHT FIRE. THE PATIENT SUFFERED BURNS TO HER MOUTH, BEHIND HER EARS, AND TO HER HAIR, AND HER FACE WAS COVERED IN SOOT. THE PATIENT IS UNDERGOING PLASTIC SURGERY. ACCORDING TO THE PSYCHIATRIST AT THE CARE HOME, THE PATIENT IS NOT A DANGER TO HERSELF OR OTHERS, AND CAN BE DISCHARGED BACK TO THE CARE HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991170 STROLLER PORTABLE, LIQUID OXYGEN BYJ CAIRE INC. 10956680

    Patients

    Seq Age Sex Outcome Treatment
    1 Other