BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE 5

    MDR report key: 8080933 · Received November 16, 2018

    Report

    Report Number
    3004972304-2018-00051
    Event Type
    Malfunction
    Date Received
    November 16, 2018
    Date of Event
    October 6, 2018
    Report Date
    January 4, 2022
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K013931
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    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. UPON RECEIVING THE UNIT, A FORMAL EVALUATION WAS COMPLETED. THERE WERE NO SIGNS OF DAMAGE OR BURNING ON THE UNIT OR ACCESSORIES. THE UNIT WAS PLUGGED IN FOR ONE HOUR, THEN RUN FOR HOUR, WITH NO OBSERVANCE OF ANY ODD SMELLS OR ODORS. AFTER, THE UUT WAS TESTED ON THE ECLIPSE FTS AND PERFORMED WITH OPERATING SPECIFICATIONS OF THE UNIT. FINALLY, THE UNIT WAS OPENED UP AND NO SIGNS OF DAMAGE, BURNING, OR FOREIGN MATTER WAS OBSERVED. BECAUSE THE UNIT PERFORMED WITHIN SPEC, NO ODORS WERE OBSERVED, AND NO DAMAGE WAS FOUND, NO FURTHER DISASSEMBLY OR INSPECTION WAS PERFORMED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER STATES THAT THERE WAS A CHEMICAL SMELL WHEN USING THE ECLIPSE. THE SMELL MADE HER VERY SICK, AND SHE FELT BAD/SICK ALL WEEKEND. THE CUSTOMER IS SEEKING TREATMENT FROM HER DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920569 ECLIPSE 5 CONCENTRATOR, OXYGEN, TRANSPORTABLE CAW CAIRE INC. 6900LN-SEQ

    Patients

    Seq Age Sex Outcome Treatment
    1 Male