BEUDAMED
    FDA Adverse Event Death Summary report: N

    VISIONAIRE 5

    MDR report key: 13953880 · Received March 30, 2022

    Report

    Report Number
    3004972304-2022-00011
    Event Type
    Death
    Date Received
    March 30, 2022
    Date of Event
    March 7, 2022
    Report Date
    May 23, 2022
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K872534
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RETURNED TO CAIRE FOR AN INVESTIGATION. 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 AN EVALUATION. THE UNIT WAS FUNCTIONING AS INTENDED WITH THE EXCEPTION BEING 1% ON THE LOW END OF SPECIFICATION ON THE 5 LPM SETTING. THE PATIENT HAS A PRESCRIPTION OF 3 LPM FOR 18 HOURS A DAY. THE DME NOTED THAT AT THE TIME OF THE LAST VISIT, THE PATIENT WAS ONLY USING THE CONCENTRATOR FOR 1.5 HOURS ON AVERAGE PER DAY. THE UNIT WAS WORKING PROPERLY AT THE PRESCRIBED SETTING.

    Description of Event or Problem · 0

    CAIRE RECEIVED NOTIFICATION OF THE BELOW INCIDENT FROM CUSTOMER (B)(6) ON MARCH 10, 2022: INCIDENT DESCRIPTION: A PATIENT DEATH WITHOUT KNOWING IF THE DEVICE WAS IN OPERATION AT THE TIME OF DEATH. THERE WAS A CALL FROM THE PATIENT'S WIDE TO INFORM US OF THE DEATH OF HER HUSBAND. WHEN THE PATIENT WAS FOUND, THE CONCENTRATOR MADE NO NOISE. SHE DOESN'T KNOW IF IT WAS ON OR OFF. PER THE PATIENT'S WIDE, IT SHOULD HAVE BEEN ON. THE PATIENT HAS THE O2 CANNULAS IN HIS NOSE, A LITTLE OUT. PER THE PATIENT'S WIFE, THERE WERE NO POWER CUTS. THE PATIENT HAD REPORTED TO HIS FAMILY A STRONG SMELL ON THE CONCENTRATOR FOR SEVERAL DAYS, WITHOUT INFORMING VITALAIRE. THE PATIENT'S WIDE THINKS THAT THE DEVICE IS INVOLVED IN THE DEATH. DURING OUR INTERVENTION AT THE HOME ON (B)(6), THE CONCENTRATOR WAS DISCONNECTED AND ON. PATIENT CONTEXT: RATHER UNSANITARY HOME. THERAPEUTIC: DOSAGE 3 L/MIN OVER 18 HOURS PER DAY. THE PATIENT HAD CANCER AND WAS CONSTANTLY BEDRIDDEN. DURING OUR LAST VISIT, COMPLIANCE WAS LOW: 1.5 HOURS PER DAY ON AVERAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157445 VISIONAIRE 5 CONCENTRATOR, OXYGEN, STATIONARY CAW CAIRE INC. AS098-5

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Death