BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPANION 5

    MDR report key: 15013508 · Received July 14, 2022

    Report

    Report Number
    3004972304-2022-00024
    Event Type
    Malfunction
    Date Received
    July 14, 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
    IA, 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-P08, INDICATING LOW O2. ALL COMPONENTS INSIDE THE CASE WERE COATED IN DUST. SIEVE DUST WAS OBSERVED BEING EXPELLED FROM THE OUTLET BARB. FOR THE SIEVE DUST TO BE EXPELLED FROM THE BARB, TWO FAULTS MUST HAVE OCCURRED ON THE UNIT. THESE FAULTS ARE SIEVE BED FAILURE AND OUTLET GAS FILTER. IT WAS INCONCLUSIVE ON THE FAULT ORDER, BUT THE UNIT WOULD ALARM FOR THE FAILURE OF THE SIEVE BED WHICH WOULD ALERT THE PATIENT OF THE FAILURE AND TO SWITCH TO AN ALTERNATIVE SOURCE OF OXYGEN.

    Description of Event or Problem · 0

    ON (B)(6) 2022, CAIRE RECEIVED A REPORT FROM ADAPTHEALTH: THE CONCENTRATOR WAS DUSTING THROUGH THE CANNULA. THE END USER HAS BEEN TO THE DOCTOR AND THE SDS FOR THE SIEVE WAS SENT PER THE DOCTOR'S REQUEST. NO INJURIES OR EFFECTS HAVE BEEN REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2349950 COMPANION 5 CONCENTRATOR, OXYGEN, STATIONARY CAW CAIRE INC. 15067005

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown