BEUDAMED
    FDA Adverse Event Death Summary report: N

    STROLLER

    MDR report key: 7802634 · Received August 21, 2018

    Report

    Report Number
    3004972304-2018-00028
    Event Type
    Death
    Date Received
    August 21, 2018
    Date of Event
    February 14, 2018
    Report Date
    October 17, 2018
    Manufacturer
    CAIRE INC.
    Product Code
    BYJ
    PMA / PMN Number
    K800742
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 CAIRE STROLLER LIQUID OXYGEN PORTABLE DEVICE INVOLVED IN THE REPORTED ALLEGED INCIDENT PASSED ALL TESTING AND MEETS ALL MANUFACTURERS SPECIFICATIONS. THERE WAS NO FIRE DAMAGE PRESENT AT THE STROLLER WHICH APPEARS TO BE CONTAINED TO THE CANULA. THE STROLLER DEVICE WAS THEREFORE ONLY INVOLVED AS THE SUPPLY OF OXYGEN REQUIRED FOR A FIRE AND NOT THE CAUSE OF FIRE.

    Additional Manufacturer Narrative · 1

    THE LADY THAT WAS AFFECTED HAS NOW PASSED. THEY ALSO FOUND OUT THAT SHE WAS SMOKING DURING OXYGEN THERAPY.

    Additional Manufacturer Narrative · 1

    THE UNIT HAS BEEN RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE AN EVALUATION HAS BEEN PERFORMED.

    Description of Event or Problem · 1

    THE PATIENT HAS BEEN USING A PORTABLE LOX PRODUCT FOR APPROX. 1YR DUE TO COPD CONDITION. UNIT IS FILLED EVERY WEDNESDAY BY VIVISOL AND A GENERAL INSPECTION MADE OF THE UNIT EVERY TIME. ON WED (B)(6) 2018 ABOUT 4 HOURS AFTER FILLING, WHILE THE PATIENT WAS IN THE RESTROOM, THE TUBE SUDDENLY EXPLODED NEAR TO THE PART APPLIED TO THE NOSE AND A FIRE BEGAN. THE PATIENT TORE THE TUBE AWAY FROM HER FACE IMMEDIATELY AND DOUSED WITH WATER. THE PATIENT'S SON, HEARING HER DISTRESS, BROKE DOWN THE DOOR AND TENDED TO HER WHILE CALLING THE EMERGENCY SERVICES. THE PATIENT SUFFERED 2ND DEGREE BURNS OVER THE WHOLE OF HER FACE AS WELL AS ON THE PALM OF HER RIGHT HAND. SHE SPENT A PERIOD OF TIME IN HOSPITAL TO RECOVER. PROGNOSIS OF DOCTORS AT THE TIME WAS THAT SHE WOULD MAKE A FULL RECOVERY, SUFFER NO PERMANENT DAMAGE AND NO SKIN GRAFTS WOULD BE NECESSARY.

    Description of Event or Problem · 1

    HOLD FOR CE 2.25

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643688 STROLLER UNIT, LIQUID OXYGEN, PORTABLE BYJ CAIRE INC. 10734067

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization