BEUDAMED
    FDA Adverse Event Death Summary report: N

    ECLIPSE 3

    MDR report key: 10314001 · Received July 23, 2020

    Report

    Report Number
    3004972304-2020-00026
    Event Type
    Death
    Date Received
    July 23, 2020
    Date of Event
    August 21, 2019
    Report Date
    December 3, 2020
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K013931
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 DEVICE WAS EVALUATED BY A THIRD PARTY CONSULTING COMPANY. BELOW IS A SUMMARY OF THE TESTING THAT WAS PERFORMED: PRIOR TO THE INSPECTION, THE CUSTOMER HAD CHARGED ALL THREE BATTERIES THAT THEY HAD ORIGINALLY PROVIDED TO THE PATIENT. OF THE THREE BATTERIES, THE FOLLOWING WAS OBSERVED: BATTERY A (LOT# 0701020855) - WHEN THE MACHINE WAS TURNED ON AND RUN OFF THIS BATTERY, IT WAS ABLE TO PROVIDE OXYGEN FOR 53 MINUTES (AT 3.0 LPM) UNTIL IT RAN OUT OF POWER AND DIED. HOWEVER, AFTER ONLY 1 MINUTE OF OPERATION, THE MACHINE STARTED BEEPING/BLINKING AND INDICATED THAT THE BATTERY WAS EMPTY. BATTERY B (SERIAL # (B)(6)) - THIS BATTERY WAS DEAD AND APPEARS TO BE UNCHARGEABLE. THE MACHINE COULD NOT OPERATE FROM THIS BATTERY. BATTERY C (SERIAL # (B)(6)) - THIS BATTERY POWERED THE MACHINE FOR 1 HOUR 18 MINUTES (AT 3.0 LPM). THIS BATTERY WORKED NORMALLY. DURING THE COURSE OF TESTING, THE MACHINE'S OXYGEN CONCENTRATION OUTPUT WAS PERIODICALLY TESTED AND THE READINGS WERE CONSISTENTLY MEASURED AROUND 3LPM AND 82-83% O2. THE YELLOW INDICATOR LIGHT ON THE MACHINE WAS EITHER ALWAYS LIT OR WAS FLASHING.

    Additional Manufacturer Narrative · 1

    IF ANY ADDITIONAL INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    AN (B)(6) YEAR OLD MALE WAS USING AN ECLIPSE 3 WHEN IT RAN OUT OF BATTERY. THE UNIT SHUT DOWN, AND THE PATIENT DIED WHILE THE MACHINE STOPPED WORKING. ((B)(6) 2019) THE PATIENT HAD COPD, AND HAD BEEN ON OXYGEN FOR APPROXIMATELY 3 MONTHS. THE ECLIPSE 3 UNIT WAS DELIVERED APPROXIMATELY 1.5 WEEKS BEFORE HIS DEATH. RIGHT FROM THE START HE STRUGGLED TO GET AIR FROM IT. THEY HAD TO GO TO THE VA FOR AN APPOINTMENT AND HE STRUGGLED TO BREATHE. HIS WIFE HAD HIM LEAN INTO THE AC AND TURNED IT ON FULL AND THAT GOT HIM THERE. THEN THEY GAVE HIM OXYGEN AT THE VA. THEY USED THE AC ON THE WAY HOME TO GET HIM HOME. THE BATTERY WAS DEAD ON THE UNIT. THE UNIT CAME WITH 3 BATTERIES. 1 WAS DEAD BEFORE THE VA TRIP, AND THE OTHERS RAN OUT TOO QUICKLY. ON (B)(6) 2019, THE PATIENT'S WIFE TOOK HIM TO GET A CAKE. THEY USED THE AC TO GET HIM THERE. HE ALSO HAD THE PORTABLE UNIT BUT NEEDED THE AC TO SUPPLEMENT. SHE WENT TO GET A WHEELCHAIR FROM THE STORE AND TOOK HIM FROM THE CAR TO THE STORE AND HE SEEMED OK WITH THE STORE AC. HIS WIFE TOOK HIM HOME AND HE ASKED THAT HE SIT OUTSIDE FOR A BIT. A NEIGHBOR CAME IN WITH THE PATIENT A FEW MINUTES LATER. HE WAS CLEARLY IN DISTRESS AND ASKING HER TO CALL 911. HE COLLAPSED ON THE FLOOR. BOTH THE WIFE AND THE NEIGHBOR GAVE HIM CPR, BUT HE CONTINUED TO STRUGGLE FOR AIR. THE OXYGEN IN THE APARTMENT DIDN'T HELP EITHER. THE EMS ARRIVED WITHIN 5 MINUTES AND THEY WORKED ON HIM FOR 30 MINUTES. WHEN HE SAT OUTSIDE HE HAD BEEN USING THE PORTABLE WHICH APPEARED TO BE FUNCTIONING BUT THE BATTERY RAN OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779358 ECLIPSE 3 CONCENTRATOR, OXYGEN, TRANSPORTABLE CAW CAIRE INC. 5900-SEQ

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death