BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BYJ

    MDR report key: 3020608 · Received March 21, 2013

    Report

    Report Number
    3004822415-2013-00001
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 7, 2013
    Manufacturer
    CAIRE, INC.
    Product Code
    BYJ
    PMA / PMN Number
    K800742
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE ALLEGED INCIDENT OCCURRED ON (B)(6) 2013. THE ALLEGED INCIDENT INVOLVED A SUBJECT CAIRE LIBERATOR 45 STATIONARY LIQUID OXYGEN RESERVOIR (SN (B)(4)). THE ALLEGED INCIDENT WAS REPORTED TO THE COMPANY ON (B)(6) 2013, BY A HOME HEALTHCARE DISTRIBUTOR IN (B)(4) VIA "PRODUCT/VENDOR QUALITY REPORT." THE HEALTHCARE QUALITY REPORT STATES THE ALLEGED INCIDENT AS THE FOLLOWING: "PT WAS BURNED WHILE USING OXYGEN FROM TANK." THE HEALTHCARE QUALITY REPORT ALSO STATES THAT THE SUBJECT UNIT WAS NOT QUARANTINED. MULTIPLE REQUESTS TO THE HEALTHCARE DISTRIBUTOR FOR FURTHER INFORMATION AND THE STATUS OF THE SUBJECT UNIT HAVE NOT BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118975 BYJ UNIT, LIQUID-OXYGEN, PORTABLE BYJ CAIRE, INC. LIBERATOR 45

    Patients

    Seq Age Sex Outcome Treatment
    1 Other