BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIONAIRE

    MDR report key: 7068118 · Received November 29, 2017

    Report

    Report Number
    3004972304-2017-00044
    Event Type
    Malfunction
    Date Received
    November 29, 2017
    Date of Event
    October 22, 2017
    Report Date
    October 17, 2018
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K872534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    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 BURNING SMELL OR THE SMOKE DESCRIBED BY THE NURSES COULD NOT BE REPLICATED THROUGH OUTTESTING THE CONCENTRATOR UNIT. INSPECTION OF THE UNIT'S CASING AND ITS INTERNAL COMPONENTS DISCOVERED NO DAMAGE OR SIGNS OF FIRE. THE CONCENTRATOR PERFORMED WELL WITHIN ITS FUNCTIONAL SPECIFICATIONS, AND IT DID NOT BEHAVE ABNORMALLY DURING EXTENDED PERIODS OF USE.

    Description of Event or Problem · 0

    THIS REPORT WAS ORIGINALLY SUBMITTED ON 10/17/2018, AND IS BEING RESUBMITTED ON 4/8/2020 AS THE ORIGINAL SUBMISSION FAILED TO GO THROUGH.

    Additional Manufacturer Narrative · 1

    THE UNIT HAS BEEN RETURNED FOR EVALUATION. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOWUP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    UNIT WAS AT A NURSING HOME. THE UNIT WAS PLUGGED IN A RESIDENT'S ROOM AND THEN TURNED ON. THE UNIT WAS LEFT RUNNING WHILE NURSES LEFT THE ROOM, THEY LATER CAME BACK AND CLAIMED THAT THERE WAS SMOKE IN THE ROOM AND THE UNIT WAS HOT. (B)(6) PICKED UP THE UNIT FROM THE NURSING HOME AND HAD HIS TECH DEPARTMENT RUN THE UNIT FOR A DAY AND A HALF. AFTER TESTING, THEY CLAIMED THERE WAS NO SMOKE COMING FROM THE UNIT, NO BURNING SMELL, AND THAT THE UNIT WAS NOT HOT. THEY COULD NOT RECREATE ANY ISSUES AND CLAIM THE UNIT IS FINE. (B)(6) TRIED TO TAKE THE UNIT BACK TO THE NURSING HOME, BUT THEY REFUSE TO USE THE UNIT AFTERWARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848421 VISIONAIRE OXYGEN CONCENTRATOR, STATIONARY CAW CAIRE INC. AS098-4

    Patients

    Seq Age Sex Outcome Treatment
    1