BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIONAIRE 5

    MDR report key: 13101791 · Received December 28, 2021

    Report

    Report Number
    3004972304-2021-00027
    Event Type
    Malfunction
    Date Received
    December 28, 2021
    Report Date
    March 31, 2022
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K872534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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. A DEVICE EVALUATION WAS PERFORMED BY CAIRE. BASED ON THE INVESTIGATION AND LOCATION OF THE DAMAGE, THE UNIT'S CIRCUIT BOARD FAILED. THE ROOT CAUSE OF THE FAILURE COULD NOT BE DETERMINED BASED ON OBSERVATIONS AND CIRCUIT BOARD FINDINGS. THE EVENT WAS CONTAINED INSIDE THE UNIT AS THE PLASTICS ARE FIRE RATED DURING A HIGH HEAT EVENT. THE END USER DID NOT REPORT AN INCIDENT WITH THE UNIT OR AN INJURY AS THE CIRCUIT BOARD WAS DISCOVERED IN CAIRE INC.'S FACILITY AS AN RMA UNIT.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RETURNED TO CAIRE FOR AN EVALUATION. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THE VISIONAIRE UNIT WAS DISCOVERED IN CAIRE REPAIRS BECAUSE SOME INTERNAL COMPONENTS OF THE UNIT SHOWED SIGNS OF HEAT DAMAGE. THERE WAS NO INCIDENT OR PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1997376 VISIONAIRE 5 CONCENTRATOR, OXYGEN, STATIONARY CAW CAIRE INC. AS098-5

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown