BEUDAMED
    FDA Adverse Event Other Summary report: N

    COMPANION 1000T

    MDR report key: 2428904 · Received January 23, 2012

    Report

    Report Number
    3004822415-2012-00001
    Event Type
    Other
    Date Received
    January 23, 2012
    Date of Event
    January 1, 2012
    Report Date
    January 4, 2012
    Manufacturer
    CAIRE, INC.
    Product Code
    BYJ
    PMA / PMN Number
    K830498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CAIRE INC. WAS NOTIFIED BY THE PT OF AN ALLEGED INCIDENT ON (B)(6) 2012. THE INCIDENT DESCRIBED BY THE PT OCCURRED ON (B)(6) 2012, AT THE PT'S HOME IN (B)(6). THE PT HAS FOUR NEW LIBERATOR LOW LOSS RESERVOIRS AND TWO NEW COMPANION 1000T PORTABLES. THE PT IS VERY ADAMANT ABOUT HER DISLIKE OF USING THE LOX EQUIPMENT. THE PT ALSO DESCRIBES HAVING TO "JIGGLE" THE EQUIPMENT ON A SCALE TO GET A READING OF HOW MUCH LOX IS IN THE UNIT, AND THAT IT CAUSES A SEVERE PROBLEM BECAUSE THIS TECHNIQUE CANNOT BE TRUSTED. THE PT ALLEGEDLY CLAIMS ON (B)(6) 2012, THE UNIT STOPPED PROVIDING OXYGEN AND THE PT HAD TO BE HOSPITALIZED. THE PT REPORTED TO NOT EVER INFORMING HER PROVIDER OF THE PROBLEM WITH CHECKING THE AMOUNT OF LOX IN THE EQUIPMENT. THE COMPANY CONTACTED THE PT'S PROVIDER. THE PROVIDER IS IN-PROCESS OF REPLACING THE TWO PORTABLE UNITS AND HAVING THEM RETURNED TO THE COMPANY FOR FURTHER INSPECTION AND EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPANION 1000T BYJ UNIT, LIQUID OXYGEN, PORTABLE BYJ CAIRE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization