BEUDAMED
    FDA Adverse Event Death Summary report: N

    SEE B.5

    MDR report key: 2750772 · Received September 14, 2012

    Report

    Report Number
    3004822415-2012-00006
    Event Type
    Death
    Date Received
    September 14, 2012
    Date of Event
    April 13, 2012
    Report Date
    September 7, 2012
    Manufacturer
    CAIRE, INC.
    Product Code
    BYJ
    PMA / PMN Number
    K861503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE COMPANY RECEIVED INFO FROM A COUNSEL REPRESENTING A HOME RESPIRATORY EQUIPMENT DISTRIBUTOR RELATED TO AN ALLEGED INCIDENT(S) INVOLVING TWO COMPANION 1000 PORTABLE LIQUID OXYGEN UNITS AND THREE STATIONARY BASE LIQUID OXYGEN UNITS. COUNSEL REPORTED THE PT (G.S.) WAS ALLEGEDLY HOSPITALIZED AND TREATED FOR A BACTERIAL LUNG INFECTION, AND SUBSEQUENTLY PASSED AWAY. BELOW ARE THE FIVE REPORTED SERIAL NUMBERS OF THE UNITS (STATIONARY #3 IS AN INVALID SERIAL NUMBER): PORTABLE (C1000) #1: SN (B)(4); PORTABLE (C1000) #1: SN (B)(4); STATIONARY BASE #1: SN (B)(4); STATIONARY BASE #2: SN (B)(4); STATIONARY BASE #3: SN (B)(4) (INVALID). THE COUNSEL CONTACTED THE COMPANY ABOUT PROVIDING ASSISTANCE IN A FILLING TEST PROTOCOL. THE COUNSEL PLANNED TO TEST AND INSPECT THE ABOVE SUBJECT UNITS. THE COMPANY IS NOT AWARE OF ANY TEST RESULTS AND HAS NOT BEEN INVOLVED WITH THE TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEE B.5 UNIT, LIQUID-OXYGEN, PORTABLE BYJ CAIRE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death