BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPANION 31T

    MDR report key: 10096141 · Received May 28, 2020

    Report

    Report Number
    3004972304-2018-00044
    Event Type
    Malfunction
    Date Received
    May 28, 2020
    Date of Event
    August 6, 2018
    Report Date
    February 1, 2019
    Manufacturer
    CAIRE INC.
    Product Code
    BYJ
    PMA / PMN Number
    K830498
    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. UNIT WAS NOT RETURNED FOR EVALUATION. THE CUSTOMER REPAIRED THE UNIT, BY CHANGING THE QDV, AND RETURNED IT TO THE FIELD.

    Description of Event or Problem · 0

    THIS REPORT WAS ORIGINALLY SUBMITTED ON 2/1/2019, AND IS BEING RESUBMITTED ON 6/4/2020 AS THE ORIGINAL REPORT FAILED TO GO THROUGH. WHEN THE PORTABLE WAS DISCONNECTED AT THE END OF FILLING; THE NIPPLE OF THE QDV WAS STUCK. A VERY LARGE SPRAY OF LIQUID OXYGENCAME OUT AND THE DEVICE RUN OUT OF OXYGEN. THE DEVICE WAS SENT FOR MAINTENANCE: THE QDV HAS BEEN CHANGED. THE PATIENT WAS NOT INJURED.

    Additional Manufacturer Narrative · 1

    UNIT IS GETTING RETURNED FOR EVALUATION BY MANUFACTURER. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS REPORT WAS ORIGINALLY SUBMITTED ON 10/18/2018, AND IS BEING RESUBMITTED ON 5/28/2020 AS THE ORIGINAL REPORT FAILED TO GO THROUGH. WHEN THE PORTABLE WAS DISCONNECTED AT THE END OF FILLING; THE NIPPLE OF THE QDV WAS STUCK. A VERY LARGE SPRAY OF LIQUID OXYGENCAME OUT AND THE DEVICE RUN OUT OF OXYGEN. THE DEVICE WAS SENT FOR MAINTENANCE: THE QDV HAS BEEN CHANGED. THE PATIENT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561479 COMPANION 31T UNIT, LIQUID OXYGEN, STATIONARY BYJ CAIRE INC. B-700893-00

    Patients

    Seq Age Sex Outcome Treatment
    1