BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAW

    MDR report key: 3062769 · Received April 12, 2013

    Report

    Report Number
    3004822415-2013-00004
    Event Type
    Death
    Date Received
    April 12, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 25, 2013
    Manufacturer
    CAIRE, INC.
    Product Code
    CAW
    PMA / PMN Number
    K013931
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT ECLIPSE 3 PORTABLE OXYGEN CONCENTRATOR UNIT WAS RETURNED TO THE COMPANY ON (B)(6) 2013, FOR FURTHER NON-DESTRUCTIVE TESTING AND EVALUATION. UPON RECEIVING THE SUBJECT UNIT: VISUAL INSPECTION OF THE EXTERIOR WAS NOTED TO BE IN ACCEPTABLE CONDITION; THERE WAS A SMALL AMOUNT OF COSMETIC DAMAGE TO THE FRONT AND BACK CASES. THE TOP AND BOTTOM OF THE SUBJECT UNIT APPEARED INTACT. IT WAS ALSO NOTED THAT THE SERIAL NUMBER (B)(4) MATCHED THE LABEL AFFIXED TO THE BOTTOM OF THE SUBJECT UNIT, AND THE HANDLE APPEARED DAMAGED ON THE RIGHT SIDE. ONE AC POWER SUPPLY, ONE DC POWER SUPPLY, AND THREE BATTERY PACKS WERE SHIPPED BACK WITH THE SUBJECT UNIT. NO DAMAGE WAS OBSERVED. TESTING RESULTS INDICATE THAT THE SUBJECT UNIT HAD SLIGHTLY LOW FLOW RATES AT 3LPM, 2LPM, AND 6LPM PULSE. NO ABNORMAL FUNCTION WAS NOTED DURING THE TEST. OXYGEN CONCENTRATIONS, POWER CONSUMPTION, TRIGGER PRESSURE, AND COMPRESSOR SPEED WERE WITHIN SPECIFICATIONS. THE INTERNAL COMPONENTS OF THE SUBJECT UNIT APPEARED TO BE INTACT. THERE WAS A SMALL AMOUNT OF DUST ON THE PCBA FAN; HOWEVER, THERE WAS NO INDICATION OF SMOKE OR DUST DAMAGE. THE DAMAGED HANDLE WAS ALSO NOTED AGAIN WHEN THE UNIT WAS OPENED FOR NONDESTRUCTIVE TESTING AND EVALUATION. TO CONCLUDE, THE OVERALL SUBJECT ECLIPSE 3 PORTABLE OXYGEN CONCENTRATOR UNIT APPEARED IN GOOD WORKING CONDITION. THE HANDLE WAS BROKEN; HOWEVER, THERE IS NO INDICATION THAT THIS DEFECT WOULD HAVE INDUCED SERIOUS INJURY.

    Description of Event or Problem · 1

    THE COMPANY WAS NOTIFIED ON (B)(6) 2013, OF AN ALLEGED INCIDENT OCCURRING ON (B)(6) 2013, INVOLVING AN ECLIPSE 3 PORTABLE OXYGEN CONCENTRATOR (SN (B)(4)). THE ALLEGED INCIDENT WAS REPORTED BY (B)(6) FROM (B)(6). THE ALLEGED INCIDENT WAS DESCRIBED AS THE FOLLOWING: "THE PT SUFFERED A STROKE, FELL DOWN, AND SUBSEQUENTLY PASSED AWAY". THE HOME HEALTH CARE DISTRIBUTOR TESTED THE SUBJECT UNIT AFTER THE ALLEGED INCIDENT AND REPORTED THAT THE UNIT WAS IN GOOD WORKING CONDITION AND MET ALL PUBLISHED SPECIFICATIONS, THEY ALSO STATED THAT THE SUBJECT UNIT WOULD NOT HAVE HAD ANY INVOLVEMENT WITH THE PT SUFFERING A STROKE. (B)(6) ALSO AGREED TO RETURN THE SUBJECT UNIT TO THE COMPANY FOR FURTHER NON-DESTRUCTIVE TESTING AND EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157560 CAW PORTABLE OXYGEN GENERATOR CAW CAIRE, INC. 5900

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death