BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIONAIRE 5

    MDR report key: 15827242 · Received November 18, 2022

    Report

    Report Number
    3004972304-2022-00043
    Event Type
    Malfunction
    Date Received
    November 18, 2022
    Report Date
    December 30, 2022
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K872534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. THE UNIT HAS BEEN RETURNED TO CAIRE'S BALL GROUND FACILITY FOR AN INVESTIGATION. 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

    "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 UNIT HAS BEEN RETURNED TO CAIRE'S BALL GROUND FACILITY FOR AN INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED WITH THE RESULTS OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THE UNIT WAS RETURNED TO CAIRE LANGENFELD RMA FOR REPAIRS. DURING REPAIRS, IT WAS IDENTIFIED THAT THE UNIT HAS BURNED CORDS AND CIRCUIT BOARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229031 VISIONAIRE 5 CONCENTRATOR, OXYGEN, STATIONARY CAW CAIRE INC. AS098-5

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown