BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIONAIRE 5

    MDR report key: 15995501 · Received December 16, 2022

    Report

    Report Number
    3004972034-2022-00049
    Event Type
    Malfunction
    Date Received
    December 16, 2022
    Date of Event
    November 24, 2022
    Report Date
    March 15, 2023
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K872534
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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.CAIRE IS ATTEMPTING TO HAVE THE UNIT RETURNED FOR AN EVALUATION. 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 INVESTIGATION. THE ENGINEERING EVALUATION CONCLUDED THE FOLLOWING: THE PATIENT REPORTED DEFLAGRATION AND A BURN, BUT ALSO REPORTED NO CREAMS, CANDLES, OR CIGARETTES WERE USED. DUE TO A PURGE ON STARTUP, THE UNIT DID NOT UNDERGO PERFORMANCE TESTING. THE UNIT HAD SIGNS OF DEBRIS TYPICAL OF USE IN A DIRTY ENVIRONMENT. ALTHOUGH THE INITIAL REPORT NOTED DEFLAGRATION, THERE WAS NO SIGN OF BURN DAMAGE ON THE UNIT. THE REPORTED PROBLEM COULD NOT BE REPRODUCED DURING INVESTIGATION. NO FURTHER INVESTIGATION REQUIRED.

    Description of Event or Problem · 0

    CAIRE RECEIVED THE BELOW REPORT FROM VIVISOL ON DECEMBER 2, 2022: PATIENT REPORTS A DEFLAGRATION AND A BURN IN THE HEAD/FACE. HE REPORTED THAT NEITHER CREAMS, CANDLES NOR CIGARETTES WERE USED. AT THE TIME OF THE INCIDENT THE CUSTOMER WAS ALONE AT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2734179 VISIONAIRE 5 CONCENTRATOR, OXYGEN, STATIONARY CAW CAIRE INC. AS098-5

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Other