BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIONAIRE 5

    MDR report key: 10057546 · Received May 14, 2020

    Report

    Report Number
    3004972304-2019-00026
    Event Type
    Injury
    Date Received
    May 14, 2020
    Date of Event
    March 28, 2019
    Report Date
    July 2, 2019
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K872534
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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." DEVICE WAS RETURNED FOR EVALUATION. THE FAILURE DESCRIBED BY THE ADVERSE EVENT FORM COULD NOT BE REPLICATED WHILE TESTING THE VISIONAIRE OXYGEN CONCENTRATOR IN QUESTION. VISUAL INSPECTIONS AND FUNCTIONAL TESTS SHOWED THAT THE CONCENTRATOR TEST UNIT IS UNDAMAGED AND IT OPERATES WITHIN ITS FUNCTIONAL SPECIFICATIONS, BOTH IN ITS OUTPUT FLOW AND IN ITS OXYGEN PURITY. FURTHERMORE, THE INCONSISTENT FLOW DESCRIBED BY THE COSTUMER COULD NOT BE CONFIRMED. THE MEASURED FLUCTUATIONS AT 4 LPM, THE UNIT'S OUTPUT FLOW AT THE TIME OF THE INCIDENT, ARE MINIMAL AND WOULD NOT BE DETECTABLE BY THE USER WITHOUT A HIGH PRECISION FLOW METER.

    Description of Event or Problem · 0

    THIS REPORT WAS ORIGINALLY SUBMITTED ON 07/02/2019, AND IS BEING RESUBMITTED ON 5/21/2020 AS THE ORIGINAL REPORT FAILED TO GO THROUGH. PER CUSTOMER, THE DIAL IS BROKEN THAT CONTROLS LITER FLOW OF OXYGEN. SOMETIMES IT JUST TURNS ENDLESSLY WITHOUT REGISTERING A LITERFLOW, LIKE 2 LITERS. SOMETIMES THE DIAL SHOWS 5 LITERS BUT NO OXYGEN FLOW. SO, INCONSISTENT OR NO READINGS. WE HAD A RESIDENT ON 4 LITERS AND HE WAS TURNING BLUE, GETTING MORE SHORT OF BREATH, AND HIS OXYGEN LEVELS DROPPING DRAMATICALLY.

    Additional Manufacturer Narrative · 1

    THE UNIT IS BEING RETURNED FOR EVALUATION. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS REPORT WAS ORIGINALLY SUBMITTED ON 04/25/2019, AND IS BEING RESUBMITTED ON 5/14/2020 AS THE ORIGINAL REPORT FAILED TO GO THROUGH. PER CUSTOMER, THE DIAL IS BROKEN THAT CONTROLS LITER FLOW OF OXYGEN. SOMETIMES IT JUST TURNS ENDLESSLY WITHOUT REGISTERING A LITERFLOW, LIKE 2 LITERS. SOMETIMES THE DIAL SHOWS 5 LITERS BUT NO OXYGEN FLOW. SO, INCONSISTENT OR NO READINGS. WE HAD A RESIDENT ON4 LITERS AND HE WAS TURNING BLUE, GETTING MORE SHORT OF BREATH, AND HIS OXYGEN LEVELS DROPPING DRAMATICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523280 VISIONAIRE 5 OXYGEN CONCENTRATOR, STATIONARY CAW CAIRE INC. AS098-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other