BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE 5

    MDR report key: 15995123 · Received December 16, 2022

    Report

    Report Number
    3004972304-2022-00048
    Event Type
    Malfunction
    Date Received
    December 16, 2022
    Date of Event
    October 7, 2022
    Report Date
    December 16, 2022
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K013931
    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. CAIRE IS ATTEMPTING TO HAVE THE DEVICE RETURNED FOR AN EVALUATION. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    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 ECLIPSE 5 UNIT WAS RETURNED TO CAIRE'S BALL GROUND, GA FACILITY FOR TESTING WITHOUT THE CAR CIGARETTE LIGHTER CHARGING ACCESSORY NOTED IN THE INCIDENT. BASED ON THE INVESTIGATION, THE UNIT SUFFERED A HIGH HEAT EVENT. THE UNIT'S EXTERIOR DID NOT SEE ANY DAMAGE APART FROM THE TUBING ON THE UNIT FROM THE EVENT AND A MEMBRANE PANEL WITH FEW BLACK MARKS. THE CIRCUIT BOARD WAS UNDAMAGED DURING THE EVENT. AFTER FURTHER INVESTIGATION, IT WAS DETERMINED NOT TO BE THE CAUSE OF THE EVENT AS THE PROPORTIONAL VALVE CIRCUIT WAS NOT COMPROMISED. WITHOUT FURTHER INFORMATION REGARDING THE EVENT AND OTHER ACCESSORIES TO TEST, THE SOURCE OF THE HIGH HEAT EVENT CANNOT BE DETERMINED. NO FURTHER TESTING IS REQUIRED. THE ECLIPSE 5 RISK ASSESSMENT (TOC-RA-1003 REV K) WAS ASSESSED AND FOUND TO BE ADEQUATE WITHOUT REVISION. ON THE RISK TOP-DOWN ANALYSIS, CASUALTY HAZARD DUE TO FIRE, RISK ID 87 AND 88 ADDRESS OPERATOR ERROR. THE RISK CONTROLS INCLUDE THE UNIT ENCLOSURE BEING MADE OF FROM V0 RATED PLASTIC FOR FIRE RESISTANCE, WARNING ON RATING LABEL, AND WARNING IN TECHNICAL MANUAL.

    Description of Event or Problem · 0

    CAIRE RECEIVED THE BELOW REPORT FROM ALEHOS ON DECEMBER 1, 2022: THE PATIENT IS ON OXYGEN THERAPY AND USES AN ECLIPSE 5. (THE PATIENT'S PRESCRIPTION IS 2L/MIN, 15 HOURS/DAY.) ON (B)(6) 2022 IN THE AFTERNOON, AFTER A CAR TRIP TO HIS HOME, THE ECLIPSE WAS CONNECTED TO THE CIGARETTE LIGHTER AND RUNNING (SET AT 2 L/MIN), SO THAT THE PATIENT IS USING THE CONCENTRATOR DURING HIS JOURNEY. THIRTY MINUTES AFTER STARTING, THE CIGARETTE LIGHTER BEGAN TO HEAT UP, SMOKE BEGAN TO FORM, AND THEN FLAMES OF 40 CM. THE PATIENT ARRIVED HOME AND MANAGED TO PUT OUT THE FIRE WITH THE GARDEN HOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1996377 ECLIPSE 5 CONCENTRATOR, OXYGEN, PORTABLE CAW CAIRE INC. 6900-C1-SEQ

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male