BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE

    MDR report key: 8030378 · Received November 1, 2018

    Report

    Report Number
    3004972304-2018-00050
    Event Type
    Malfunction
    Date Received
    November 1, 2018
    Date of Event
    September 22, 2018
    Report Date
    June 25, 2020
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K013931
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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 WAS RETURNED TO CAIRE ON FEBRUARY 28, 2020. THE UNIT WAS EVALUATED. THE ECLIPSE 5 UNIT ASSOCIATED WITH THE ADVERSE EVENT FUNCTIONED NORMALLY THROUGHOUT TESTING. OUTPUT FLOW, OUTPUT OXYGEN PURITY, AND POWER CONSUMPTION MET FUNCTIONAL SPECIFICATIONS WITHOUT EXHIBITING ANY ABNORMAL BEHAVIOR. ACCORDING TO THE REPORTED DESCRIPTION OF THE EVENT, THE UNIT'S DC POWER SUPPLY GOT TOO HOT AND IT BLEW A FUSE IN THE VEHICLE, HOWEVER THE ASSOCIATED DC POWER SUPPLY WAS NOT PROVIDED FOR TESTING. NO FURTHER DETAILS WERE PROVIDED AS TO WHAT TYPE OF VEHICLE THE UNIT WAS IN OR THE SPECIFICS OF THE ELECTRICAL FAILURE THE VEHICLE EXPERIENCED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DC POWER SUPPLY GOT TOO HOT AND BLEW FUSE IN THE VEHICLE. CUSTOMER HAD TO FIND AN ALTERNATE SOURCE OF POWER AT A LOCAL RESTAURANT. NO INJURY TO END USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870584 ECLIPSE CONCENTRATOR, OXYGEN, TRANSPORTABLE CAW CAIRE INC. 6900LN-SEQ

    Patients

    Seq Age Sex Outcome Treatment
    1