BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPANION 5

    MDR report key: 20529467 · Received October 24, 2024

    Report

    Report Number
    3004972304-2024-00012
    Event Type
    Malfunction
    Date Received
    October 24, 2024
    Date of Event
    May 3, 2024
    Report Date
    October 24, 2024
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    UDI-DI
    M766150670050
    PMA / PMN Number
    K121167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE MACHINE IN QUESTION IS NOT A LIFE SUPPORTING DEVICE. IT IS USED FOR OXYGEN THERAPY. THE UNIT WAS RETURNED DISPLAYING ALARM CODE AL-P08, INDICATING LOW OXYGEN. THE USER MANUAL INSTRUCTS THE USER TO NOT IGNORE THE ALARM, TO SWITCH TO THE BACKUP SOURCE OF OXYGEN, AND TO NOTIFY THE HEALTHCARE PROVIDER IMMEDIATELY. A BACK UP SOURCE OF OXYGEN IS RECOMMENDED PER USER MANUAL. THE UNIT SHOWED THE SIEVE DUST BEING EXPELLED FROM THE OUTLET BARB, SUGGESTING THAT THE UNIT WAS ALLOWED TO RUN WHILE ALARMING FOR AN EXTENDED AMOUNT OF TIME. THE MACHINE WILL SHOW YELLOW LED LIGHTS AND THE ALARM WILL SOUND WHEN THERE IS A MALFUNCTION. DUE TO EXPECTED MOVEMENT OF THE SIEVE MATERIAL (ZEOLYTE) IN THE SIEVE BED, AFTER A LONG PERIOD OF TIME A MECHANICAL BREAKDOWN CAUSES THE MATERIAL TO BREAK DOWN INTO DUST-SIZE PARTICLES WHICH, BY DESIGN, ARE BLOCKED BY SUBSEQUENT FILTERS IN THE GAS PATHWAYS WHICH CAUSES GAS PURITY ALARMS (ALPL08). IN THE CURRENT CASE, AS THE ALARM WAS IGNORED FOR A LONG TIME, A VERY SMALL AMOUNT OF SIEVE DUST COULD SLOWLY PENETRATE THROUGH THE FILTER. THE INSPECTION OF THE DEVICE REVEALED THAT THERE WAS AN OUTLET GAS FILTER FAILURE. THE RISK ASSESSMENT ASSOCIATED WITH THIS DEVICE INDICATES THE RISK AND HAZARD OF THE FILTER FAILURE AS A LOW. NO TREND IS DETECTED AT THIS TIME AND THE OCCURRENCE THRESHOLD HAS NOT BEEN EXCEEDED. THE MOST RECENT ANALYSIS SHOWED THE OCCURRENCE OF THIS EVENT TO BELOW AT .016%. 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.

    Description of Event or Problem · 0

    THE UNIT WAS RETURNED DISPLAYING ALARM CODE AL-P08, INDICATING LOW OXYGEN. THE USER MANUAL INSTRUCTS THE USER TO NOT IGNORE THE ALARM, TO SWITCH TO THE BACKUP SOURCE OF OXYGEN, AND TO NOTIFY THE HEALTHCARE PROVIDER IMMEDIATELY. A BACKUP SOURCE OF OXYGEN IS RECOMMENDED PER USER MANUAL. THE UNIT SHOWED THE SIEVE DUST BEING EXPELLED FROM THE OUTLET BARB, SUGGESTING THAT THE UNIT WAS ALLOWED TO RUN WHILE ALARMING FOR AN EXTENDED AMOUNT OF TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2579958 COMPANION 5 CONCENTRATOR, OXYGEN, STATIONARY CAW CAIRE INC. 15067005 M766150670050

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male