BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPANION 5

    MDR report key: 14991502 · Received July 12, 2022

    Report

    Report Number
    3004972304-2022-00022
    Event Type
    Malfunction
    Date Received
    July 12, 2022
    Report Date
    August 30, 2022
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K121167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 DEVICE HAS BEEN RETURNED TO CAIRE FOR AN INVESTIGATION. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    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 DEVICE WAS RETURNED TO CAIRE FOR AN EVALUATION. THE COMPANION 5 UNIT WAS DISPLAYING ALARM CODE AL-P04, INDICATING LOW O2. SOME COMPONENTS INSIDE THE CASE (SIEVE BEDS, AND VALVES) WERE COATED IN DUST. SIEVE DUST WAS NOT OBSERVED BEING EXPELLED FROM THE OUTLET BARB OR IN THE ROTAMETER TUBE, AND THE OUTLET FILTER WAS INTACT, THEREFORE THE SIEVE CANNOT REACH THE PATIENT. DUST OBSERVED IN THE CASE COMPONENTS MAY INDICATE THAT INTERNAL MECHANICAL COMPONENTS HAVE BEEN DAMAGED, LEADING TO THE AL-P04 ALARM.

    Description of Event or Problem · 0

    ON JUNE 13, 2022, CAIRE RECEIVED A REPORT FROM (B)(4): THREE COMPANION 5 UNITS WERE NOTED TO HAVE SIEVE DUST IN THE O2 OUTLET. THERE WERE NO INJURIES REPORTED. THIS REPORT IS FOR COMPANION 5, S/N (B)(4). REF. 3004972304-2022-00021 (S/N (B)(4)) AND 3004972304-2022-00023 (S/N (B)(4)) FOR THE MEDWATCH REPORTS FOR THE OTHER COMPANION 5 UNITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700830 COMPANION 5 CONCENTRATOR, OXYGEN, STATIONARY CAW CAIRE INC. 15067005

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown