BEUDAMED
    FDA Adverse Event Death Summary report: N

    HELIOS

    MDR report key: 10133524 · Received June 9, 2020

    Report

    Report Number
    3004972304-2020-00016
    Event Type
    Death
    Date Received
    June 9, 2020
    Date of Event
    April 11, 2020
    Report Date
    August 20, 2020
    Manufacturer
    CAIRE INC.
    Product Code
    BYJ
    PMA / PMN Number
    K860937
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 PATIENT WAS USING A HELIOS LIQUID OXYGEN RESERVOIR AT THE TIME OF THE INCIDENT; HOWEVER, A SECOND HELIOS AND A PORTABLE COMPANION 1000 UNIT WERE IN THE FIRE. ONLY ONE HELIOS UNIT WAS INVOLVED IN THE INCIDENT, AND THE OTHER TWO UNITS (ONE HELIOS, ONE COMPANION 1000) WERE IN THE ROOM AT THE TIME OF THE INCIDENT. ALL THREE UNITS HAVE BEEN RETURNED TO CAIRE FOR AN EVALUATION. BOTH HELIOS U46 LIQUID OXYGEN RESERVOIRS WERE EVALUATED. WHILE THE OPERATING PRESSURES WERE SLIGHTLY OUT OF THE SPECIFIED LIMITS, BOTH UNITS FUNCTIONED NORMALLY AND WERE DEEMED TO BE ACCEPTABLE FOR CONTINUED USE. ALL FIRE OR HEAT RELATED DAMAGE ON EITHER UNIT WAS FOUND TO BE COSMETIC, AND NEITHER UNIT PROVIDED ANY EVIDENCE OF DIRECT INVOLVEMENT IN THE FIRE. THE CANNULA TUBING WAS NOT RETURNED WITH THE UNITS. IT WAS NOT POSSIBLE TO DETERMINE WHICH UNIT WAS IN USE AT THE TIME OF THE INCIDENT. THE SERIAL NUMBERS OF THE UNITS WERE DETERMINED WHEN THE UNITS WERE RETURNED: 1. HELIOS U46 RESERVOIR, MODEL #: B-702099-00, S/N: (B)(6). 2. HELIOS U46 RESERVOIR, MODEL #: B-702099-00, S/N: (B)(6). 3. COMPANION C1000 PORTABLE LIQUID OXYGEN RESERVOIR, S/N: (B)(6).

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS USING A HELIOS LIQUID OXYGEN RESERVOIR AT THE TIME OF THE INCIDENT; HOWEVER, A SECOND HELIOS AND A PORTABLE COMPANION 1000 UNIT WERE IN THE FIRE. ALL THREE UNITS HAVE BEEN RETURNED TO CAIRE FOR AN EVALUATION. ANY ADDITIONAL INFORMATION WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE PATIENT WAS SMOKING WHILE ON OXYGEN. THE PATIENT HAD TWO LIQUID OXYGEN RESERVOIRS AND A COMPANION 1000 PORTABLE. THE PATIENT WAS ON A RESERVOIR AT THE TIME OF THE INCIDENT, AND THE OTHER TWO LIQUID OXYGEN UNITS (RESERVOIR AND PORTABLE) WERE IN THE FIRE. THE DISTRIBUTOR IS NOT SURE WHICH RESERVOIR THE PATIENT WAS USING DURING THE EVENT. THE CANNULA TUBING WAS GONE BEFORE THEY WERE NOTIFIED. THE PATIENT IS DECEASED. THE LIQUID OXYGEN UNITS WERE DELIVERED (B)(6) 2020 AND FILLED ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598298 HELIOS UNIT, LIQUID OXYGEN, STATIONARY BYJ CAIRE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death