BEUDAMED
    FDA Adverse Event Other Summary report: N

    COMPANION 1000

    MDR report key: 3180068 · Received June 13, 2013

    Report

    Report Number
    3004822415-2013-00009
    Event Type
    Other
    Date Received
    June 13, 2013
    Date of Event
    February 19, 2013
    Report Date
    May 9, 2013
    Manufacturer
    CAIRE, INC.
    Product Code
    BYJ
    PMA / PMN Number
    K861503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS NOTIFIED OF AN ALLEGED INCIDENT THAT OCCURRED AT UNK FACILITY AND LOCATION ON (B)(6) 2013. THE ALLEGED INCIDENT OCCURRED ON (B)(6) 2013, AND INVOLVED A COMPANION 1000 PORTABLE LIQUID OXYGEN UNIT AND A BASE COMPANION LIQUID OXYGEN RESERVOIR. THE ALLEGED INCIDENT IS DESCRIBED THAT DURING A TRANSFILL BETWEEN THE PORTABLE UNIT AND THE BASE UNIT, THE MALE-FEMALE COUPLINGS FROZE TOGETHER. THE CUSTOMER ADMITS THAT THE TECHNICIANS DID NOT FOLLOW PROPER FILLING PROCEDURES. ONCE THE TECHS COULD NOT DISENGAGE THE TWO UNITS, THE TECHS FORCED THE PORTABLE UNIT OFF CAUSING THE FEMALE COUPLING TO SHEAR OFF. NO INJURIES OR PROPERTY DAMAGE WAS REPORTED. THE BASE UNIT ALSO APPEARED UNDAMAGED. THE COMPANY HAS DETAILED FILLING PROCEDURES IN THE USER MANUAL, ALONG WITH INSTRUCTIONS TO PREVENT THE COUPLINGS FROM FREEZING TOGETHER AND INSTRUCTIONS ON HOW TO SAFELY DISENGAGE. LABELING ALSO STATES THAT MANUAL MUST BE READ BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268477 COMPANION 1000 UNIT, LIQUID-OXYGEN, PORTABLE BYJ CAIRE, INC. B-775099-00

    Patients

    Seq Age Sex Outcome Treatment
    1 Other