BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPANION 1000

    MDR report key: 12210395 · Received July 22, 2021

    Report

    Report Number
    3004972304-2021-00018
    Event Type
    Injury
    Date Received
    July 22, 2021
    Report Date
    September 16, 2021
    Product Code
    BYJ
    PMA / PMN Number
    K861503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    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 UNIT WAS RETURNED TO CAIRE FOR AN EVALUATION. THE EVALUATION OF THE COMPANION C1000 LIQUID OXYGEN PORTABLE UNIT COULD NOT REPLICATE THE ADVERSE EVENT, LEAKAGE OF LIQUID OXYGEN. WHILE THE EVALUATION FOUND THAT THE TEST UNIT DOES NOT MEET ALL OF ITS FUNCTIONAL SPECIFICATIONS, IT IS UNLIKELY THAT IT WOULD LEAK LIQUID OXYGEN WHILE OPERATING. LEAKS WERE FOUND ON THE INLET AND OUTLET OF THE FLOW CONTROL VALVE AND ON THE VENT VALVE, HOWEVER THESE ARE POSITIONED IN AREAS WHERE ONLY GASEOUS OXYGEN WOULD BE FOUND DURING NORMAL USE. THE ADVERSE EVENT FORM STATES THAT THE UNIT WAS POSITIONED IN BETWEEN THE PATIENT'S LEGS AT THE TIME OF THE INCIDENT. THIS PRESENTS AN OPPORTUNITY FOR THE UNIT TO BE TIPPED OVER. IF THIS OCCURS, THEN BOTH GASEOUS AND LIQUID OXYGEN CAN ESCAPE FROM THE UNIT. THE USER MANUAL STATES THAT THE UNIT SHOULD BE KEPT UPRIGHT TO PREVENT THIS FROM HAPPENING.

    Additional Manufacturer Narrative · 1

    THE UNIT HAS BEEN RETURNED TO CAIRE FOR EVALUATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE DISTRIBUTOR LINDE GAS RECEIVED A PHYSICIAN'S PHONE REPORT THAT A PATIENT STAYING AT THEIR PNEUMOLOGY CLINIC WAS HURT BY LOX SPILLED FROM A PORTABLE LAID BETWEEN THE PATIENT'S LEGS. THE PATIENT WAS TRANSFERRED FROM THEIR WARD TO ANOTHER CLINIC FOR AN INSPECTION, AND THEY USED A FILLED PORTABLE FOR THE TRANSPORT. IT WAS A UNIVERSITY HOSPITAL IN (B)(6). THE PATIENT WAS BURNED BY CRYO-OXYGEN ON HIS LEGS AND SUBSEQUENTLY TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1107219 COMPANION 1000 PORTABLE LIQUID OXYGEN BYJ B-700883-00

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other