BEUDAMED
    FDA Adverse Event Death Summary report: N

    VISIONAIRE 5

    MDR report key: 7878614 · Received September 14, 2018

    Report

    Report Number
    3004972304-2018-00042
    Event Type
    Death
    Date Received
    September 14, 2018
    Date of Event
    August 17, 2018
    Report Date
    September 12, 2019
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K872534
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. UNIT WAS EVALUATED BY A THIRD PARTY (RIMKUS). THEY CONCLUDED THE FOLLOWING: THERE WERE NO FAULTS OR MALFUNCTIONS WHEN THE AIRSEP VISIONAIRE 5 OXYGEN CONCENTRATOR WAS OPERATED AND TESTED ON JULY 19, 2019. THE AIRSEP VISIONAIRE 5 OXYGEN CONCENTRATOR APPEARED TO FUNCTION AS NORMALLY EXPECTED WHEN IT WAS OPERATED AND TESTED ON JULY 19, 2019.

    Additional Manufacturer Narrative · 0

    DURING FURTHER INVESTIGATION, THE FOLLOWING WAS IDENTIFIED: MAXON MOTORS PERFORMED AN EXTENSIVE ROOT-CAUSE ANALYSIS AND FAILURE INVESTIGATION. MAXON DID NOT IDENTIFY ANY DESIGN ISSUES TO CAUSE THIS FAILURE MODE. MAXON FOCUSED ON FORCING MALFUNCTION BY ARTIFICIALLY DAMAGING COMPONENTS TO MIMIC IMPROPER HANDLING DURING INSTALLATION OR SERVICE IN THE FIELD. EVEN IN THE CASE OF A FORCED DAMAGE, THE BURNT PCB AREAS OBSERVED BY ALL TESTS HAVE BEEN LESS THAN BY THE RETURN SHIPMENTS. CONCENTRATED OXYGEN OR AIR FLOW MAY HAVE BEEN AN INFLUENCING FACTOR WHICH CAN INCREASE THE BURNING OR FLAMING EFFECT AS SEEN IN THE RETURNED UNITS. THERE HAVE NOT BEEN ANY SYSTEMIC ISSUES IDENTIFIED. WE WILL CONTINUE TO MONITOR COMPLAINTS.

    Additional Manufacturer Narrative · 0

    UNIT WAS RETURNED FOR AN EVALUATION. BASED ON THE DAMAGE FOUND IN THE UNIT, IT CAN BE CONCLUDED THAT THE INCIDENT STARTED INTERNALLY. IT CAN BE SEEN THAT THE INCIDENT STARTED FROM THE MOTOR CONTROL BOARD. THE INCIDENT HAPPENED LONG ENOUGH IN ORDER TO BURN THE FILTER AND CASING IN FRONT OF THE MOTOR CONTROL BOARD. THE MOTOR CONTROL BOARD FROM THE UNIT WAS COMPARED TO A NEW MOTOR CONTROL BOARD FOR RESISTANCE ACROSS THE PLANES. THE BOARD ON THE UNIT MEASURED 18.7 OHMS WHILE THE NEW BOARD MEASURED 359K OHMS. NO OTHER INTERNAL PARTS WERE DAMAGED DURING THE EVENT OTHER THAT THE FILTER AND A SMALL SECTION OF THE FRONT PLASTIC. FROM THESE OBSERVATIONS, THE INCIDENT STARTED FROM THE MOTOR CONTROL BOARD.

    Description of Event or Problem · 0

    THIS REPORT WAS ORIGINALLY SUBMITTED ON 9/12/2019, AND IS BEING RESUBMITTED ON 7/6/2020 AS THE ORIGINAL REPORT FAILED TO GO THROUGH. NOTE: THE 2 PREVIOUS FOLLOW-UP MDR REPORTS (4/5/2019, 10/25/2019) SUBMITTED FOR 3004972304-2018-00042 WERE INCORRECTLY SUBMITTED UNDER THIS REPORT NUMBER, AND HAVE BEEN RESUBMITTED AS FOLLOW-UP REPORTS FOR 3004972304-2018-00061. PROVIDER REPORT ONE OF THE END USER PASSES AWAY WHILE ON AN AIRSEP VISONAIRE CONCENTRATOR WITH SN: (B)(6). THE FAMILY OF THE DECEASED BLAMES THE EQUIPMENT, AS THE MACHINE HAS ALARMED. WHEN THEIR DELIVERY TECHNICIAN ARRIVED, HE CHECKED IT AND FOUND THE CONCENTRATOR IN WORKING ORDER WITH BACKUP OXYGEN AVAILABLE, BUT SUSPECTED THE SPECIALTY MASK BEING USED AS THE SOURCE OF THE ISSUE.

    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

    PROVIDER REPORT ONE OF THE END USER PASSES AWAY WHILE ON AN AIRSEP VISONAIRE CONCENTRATOR WITH SN: (B)(4). THE FAMILY OF THE DECEASED BLAMES THE EQUIPMENT, AS THE MACHINE HAS ALARMED. WHEN THEIR DELIVERY TECHNICIAN ARRIVED, HE CHECKED IT AND FOUND THE CONCENTRATOR IN WORKING ORDER WITH BACKUP OXYGEN AVAILABLE, BUT SUSPECTED THE SPECIALTY MASK BEING USED AS THE SOURCE OF THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719821 VISIONAIRE 5 OXYGEN CONCENTRATOR, STATIONARY CAW CAIRE INC. AS098-4

    Patients

    Seq Age Sex Outcome Treatment
    1 Death