BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMPANION 5

    MDR report key: 19282385 · Received May 9, 2024

    Report

    Report Number
    3004972304-2024-00003
    Event Type
    Death
    Date Received
    May 9, 2024
    Date of Event
    March 22, 2024
    Report Date
    August 12, 2024
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K121167
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    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 INFORMATION PROVIDED REPRESENTS THE BEST INFORMATION AVAILABLE TO CAIRE. THE INITIAL REPORTER PROVIDED CAIRE WITH A NON-CAIRE SERIAL NUMBER (B)(6). CAIRE CONTINUES TO ATTEMPT TO RETRIEVE THE CORRECT SERIAL NUMBER FROM THE REPORTER, WITHOUT WHICH THE MANUFACTURE DATE OF THE DEVICE CANNOT BE DETERMINED. THE DEVICE(S) WILL NOT BE AVAILABLE FOR ENGINEERING EVALUATION. THE EVENT DESCRIPTION REFERENCES A FIRE MARSHAL REPORT THAT INDICATES A SOURCE OF IGNITION WAS PRESENT WITH THE OXYGEN GENERATING EQUIPMENT, REPRESENTING MISUSE OF THE DEVICE PER THE INSTRUCTIONS FOR USE. "NO SMOKING" SYMBOLS (REG# (B)(4) ARE AFFIXED TO THE FACE OF THE UNITS. THROUGHOUT THE UNIT IFU, WARNINGS STATE NOT TO ALLOW SMOKING OR OPEN FLAME NEAR THE DEVICE AND TO KEEP ALL FLAMMABLE MATERIALS AWAY FROM THE EQUIPMENT. ADDITIONAL WARNINGS STATE THAT SMOKING WHILE WEARING AN OXYGEN CANNULA CAN CAUSE FACIAL BURNS AND POSSIBLY RESULT IN DEATH. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ADDITIONAL INFORMAITON IF IT BECOMES AVAILABLE.

    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. **UDI RELATED DATA QUALITY UPDATES ONLY** SECTION D4 PRIMARY UNIQUE DEVICE IDENTIFIER (UDIS) # IS INTENTIONALLY BLANK. THE UNIT SERIAL NUMBER AND UDI ARE UNKNOWN DESPITE MULTIPLE ATTEMPTS TO IDENTIFY THIS INFORMATION. THE REPORTER COULD NOT PROVIDE THIS INFORMATION AND THE DEVICE COULD NOT BE RETURNED TO CAIRE.

    Description of Event or Problem · 0

    AS REPORTED: SPOUSE OF PATIENT CALLED TO REPORT THAT PATIENT HAD EXPIRED IN FIRE IN HER HOME. PER CALL, HE TRIED TO ASSIST PATIENT BUT WAS UNABLE TO. REPORT RECEIVED FROM COUNTY FIRE MARSHAL ON (B)(6) 2024 INDICATES THAT HEAT SOURCE: LIGHTER CIGARETTE, CIGAR; ITEM FIRST IGNITED: PIPE DUCT CONDUIT, HOSE; TYPE OF MATERIAL FIRST IGNITED: PLASTIC; CAUSE OF IGNITION: UNINTENTIONAL, FACTORS CONTRIBUTING TO IGNITION: MISUSE OF MATERIAL OR PRODUCT, OTHER; EQUIPMENT INVOLVED IN IGNITION: OXYGEN ADMINISTRATION EQUIPMENT. ENTIRE STRUCTURE AS WELL AS CONTENTS OF HOME DESTROYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483602 COMPANION 5 CONCENTRATOR, OXYGEN, STATIONARY CAW CAIRE INC. 15067005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Death