BEUDAMED
    FDA Adverse Event Death Summary report: N

    VISIONAIRE 5

    MDR report key: 15334967 · Received September 1, 2022

    Report

    Report Number
    3004972304-2022-00033
    Event Type
    Death
    Date Received
    September 1, 2022
    Date of Event
    July 19, 2022
    Report Date
    September 1, 2022
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K872534
    Adverse Event
    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. CAIRE IS CONTACTING VIVISOL TO OBTAIN MORE INFORMATION ABOUT THE INCIDENT, AS WELL AS TO HAVE THE UNIT RETURNED FOR AN INVESTIGATION. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON AUGUST 17, 2022, CAIRE RECEIVED A REPORT FROM VIVISOL OF THE BELOW INCIDENT: ACCORDING TO THE INFORMATION OF HER HUSBAND, A FEMALE PATIENT PASSED AWAY ON (B)(6) 2022 WHILE OPERATING A STATIONARY OXYGEN CONCENTRATOR UNIT VISIONAIRE 5 (PN: AS098-5, SN: (B)(4)). THE PATIENT RECEIVED HER NEW V5 UNIT IN (B)(6) 2022. THIS WAS THE FIRST UNIT THAT VIVISOL AT HAS SUPPLIED TO HER. IN THE COURSE OF THE POLICE INVESTIGATION THE DEVICE HAS BEEN SEIZED IN EVIDENCE AT THE POLICE STATION "(B)(6)" [A LOCAL POLICE STATION IN NORTHEAST (B)(6)].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2852411 VISIONAIRE 5 CONCENTRATOR, OXYGEN, STATIONARY CAW CAIRE INC. AS098-5

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Death