BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIONAIRE 5

    MDR report key: 12928074 · Received December 3, 2021

    Report

    Report Number
    3004972304-2021-00025
    Event Type
    Malfunction
    Date Received
    December 3, 2021
    Date of Event
    October 27, 2021
    Report Date
    January 18, 2022
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K872534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 WAS RETURNED TO CAIRE FOR AN EVALUATION. BASED ON THE EVIDENCE COLLECTED, THE UNIT HAD A SIEVE BED FILTER FAILURE. THE SIEVE BEDS WERE NOT TAKEN APART FOR FURTHER INVESTIGATION BUT SIEVE DUST IN AND AROUND THE UNIT IS AN INDICATION OF THIS FAILURE. THOUGH THE SIEVE BED FILTER FAILED, THE INTERIOR OF THE ROTAMETER REMAINS CLEAN DUE TO THE ADDITIONAL FILTER IN THE PRODUCT TANK.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE PATIENT CALLED THEIR DISTRIBUTOR VIVISOL, SAYING THAT THEIR VISIONAIRE 5 IS VERY NOISY AND HAS DUST COMING OUT OF IT. THE CONTRACTOR PICKED THE UNIT UP, AND THE PATIENT LETS THE CONTRACTOR KNOW THAT THE UNIT EXPLODED. NO CANNULA WAS ATTACHED TO THE UNIT AT THIS POINT, AND THE PATIENT WAS NOT HARMED. WHEN THE UNIT WAS INSPECTED BY VIVISOL, THEY NOTICED ZEOLITH WHICH CAME FROM THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1820694 VISIONAIRE 5 CONCENTRATOR, OXYGEN, STATIONARY CAW CAIRE INC. AS098-5

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown