BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPANION 5

    MDR report key: 16311942 · Received February 7, 2023

    Report

    Report Number
    3004972304-2023-00001
    Event Type
    Malfunction
    Date Received
    February 7, 2023
    Date of Event
    January 7, 2023
    Report Date
    February 7, 2023
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K121167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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 COMPANION 5 UNIT WAS RETURNED TO CAIRE'S BALL GROUND, GA FACILITY FOR EVALUATION. THE CONDITION OF THE COMPANION 5 UNIT WAS TOO DETERIORATED TO ALLOW FUNCTIONAL TESTING TO BE COMPLETED. SEVERE FIRE DAMAGE WAS OBSERVED.

    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. CAIRE IS WORKING WITH THE CUSTOMER TO GET MORE INFORMATION ON THE INCIDENT AND TO HAVE THE UNIT RETURNED FOR AN INVESTIGATION. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    CAIRE WAS NOTIFIED ON (B)(6) 2023 OF THE BELOW INCIDENT FROM AIR LIQUIDE COLOMBIA: THE FAMILY WAS ON THE GROUND FLOOR, AND THE CONCENTRATOR (CAIRE'S COMPANION 5 DEVICE) AND TWO CYLINDERS WERE IN THE PATIENT'S ROOM ON THE SECOND FLOOR. THEY HEARD AN EXPLOSION AND A FIRE STARTED IN THE ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1495113 COMPANION 5 CONCENTRATOR, OXYGEN, STATIONARY CAW CAIRE INC. 15067005

    Patients

    Seq Age Sex Outcome Treatment
    1 Female