BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAIRE LOW LOSS 41L

    MDR report key: 2091678 · Received April 29, 2011

    Report

    Report Number
    3004822415-2011-00009
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 30, 2011
    Manufacturer
    CAIRE, INC.
    Product Code
    BYJ
    PMA / PMN Number
    K800742
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAIRE WILL CONTINUE ITS ATTEMPTS TO CONTACT THE DISTRIBUTOR FOR FURTHER INFO, AS WELL AS TO HAVE THE INVOLVED UNIT RETURNED FOR FULL-INSPECTION AND TESTING.

    Description of Event or Problem · 1

    CAIRE WAS CONTACTED OF THE ALLEGED INCIDENT ON (B)(6) 2011, BY A CONTRACT ADMINISTRATOR FROM A DISTRIBUTOR, VIA A PRODUCT/VENDOR QUALITY REPORT. THE DETAILS OF THE ALLEGED INCIDENT WERE OUTLINED WITHIN THE PRODUCT/VENDOR QUALITY REPORT, ALONG WITH A CONTACT NAME (B)(6) AT THE DISTRIBUTOR FOR FURTHER DETAILS AND INFO. CAIRE HAS LEFT 5 VOICEMAILS FOR (B)(6) WITH NO RETURNED CALL, THE VOICEMAILS WERE LEFT ON THE FOLLOWING DATES: 3/20/2011, 3/31/2011, 4/1/2011, 4/11/2011, AND 4/26/2011. CAIRE HAS ALSO SENT AN EMAIL AND LEFT A VOICE MAIL TO THE INITIAL REPORTER, THE CONTRACT ADMINISTRATOR, WITH NO RESPONSE OR NO RETURNED CALL. THE ALLEGED INCIDENT IS DESCRIBED IN THE PRODUCT/VENDOR QUALITY REPORT AS THE FOLLOWING: "[PT/VENDOR STATES THAT]: PAID CAREGIVER WAS SPRAYED WITH LIQ O2 IN THE PROCESS OF CONNECTING AND RECONNECTING THE PORTABLE." THE PRODUCT/VENDOR QUALITY REPORT ALSO STATES THAT THE INVOLVED EQUIPMENT HAS BEEN QUARANTINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAIRE LOW LOSS 41L BYJ UNIT, LIQUID OXYGEN, PORTABLE BYJ CAIRE, INC. 11177784

    Patients

    Seq Age Sex Outcome Treatment
    1 Other