BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIONAIRE

    MDR report key: 11467294 · Received March 11, 2021

    Report

    Report Number
    3004972304-2021-00002
    Event Type
    Injury
    Date Received
    March 11, 2021
    Report Date
    April 19, 2021
    Product Code
    CAW
    PMA / PMN Number
    K872534
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 DEVICE WAS RETURNED TO CAIRE FOR AN EVALUATION. THE FAILURE DESCRIBED BY THE CUSTOMER 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, WITH THE EXCEPTION OF A RELATIVELY LOW OUTPUT FLOW, IT OPERATES WITHIN ITS FUNCTIONAL SPECIFICATIONS. ADDITIONALLY, ALL ALARMS ARE FUNCTIONAL AND OPERATE AS INTENDED.

    Additional Manufacturer Narrative · 1

    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 VISIONAIRE 5L OXYGEN CONCENTRATOR IS INTENDED FOR THE ADMINISTRATION OF SUPPLEMENTAL OXYGEN. THE DEVICE IS NOT INTENDED FOR LIFE-SUPPORT, NOR DOES IT PROVIDE ANY PATIENT MONITORING CAPABILITES. THE DEVICE HAS BEEN RETURNED TO CAIRE FOR AN EVALUATION. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VISIONAIRE DEVICE STOPPED WORKING, AND NO ALARMS SOUNDED TO ALERT THE PATIENT OR CARER. THE PATIENT'S SATS DROPPED TO 46, AND AN AMBULANCE WAS CALLED. THE PATIENT WAS NOT ADMITTED TO THE HOSPITAL, AS THEY MOVED THE PATIENT ONTO A SECOND CONCENTRATOR, AND THE PATIENT'S SATS IMMEDIATELY IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358292 VISIONAIRE CONCENTRATOR, OXYGEN, STATIONARY CAW AS098-7

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R