BEUDAMED
    FDA Adverse Event Other Summary report: N

    ECLIPSE OXYGEN CONCENTRATOR

    MDR report key: 2470712 · Received February 24, 2012

    Report

    Report Number
    3004822415-2012-00002
    Event Type
    Other
    Date Received
    February 24, 2012
    Date of Event
    January 27, 2012
    Report Date
    February 24, 2012
    Manufacturer
    CAIRE, INC.
    Product Code
    CAW
    PMA / PMN Number
    K013931
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED ON (B)(6) 2012, OF AN ALLEGED INCIDENT INVOLVING ECLIPSE PORTABLE CONCENTRATOR FROM A HEALTHCARE DISTRIBUTOR (SN (B)(4)). THE ALLEGED INCIDENT OCCURRED ON (B)(6) 2011, ON A CRUISE SHIP. THE PT REPORTED THE INCIDENT TO THEIR PROVIDER ON (B)(6) 2012. THE PT IS FROM (B)(6). THE PT DESCRIBED THE ALLEGED INCIDENT AS THE FOLLOWING: HIS CONCENTRATOR QUIT WORKING WHILE ON HIS CRUISE SHIP AND PER THE PT, ¿THE CRUISE SHIP DID NOT HAVE APPROPRIATE SUPPLIES TO ALLOW HIM TO USE THEIR CONCENTRATORS.¿ THE PT STATED THAT HE WENT WITHOUT HIS OXYGEN FOR APPROX 5 DAYS. THE PT REPORTS THAT HE WAS HOSPITALIZED FOR APPROX 5 DAYS AS A RESULTS OF BEING WITHOUT HIS OXYGEN. THE HEALTHCARE PROVIDER REPORTED THAT THE SUBJECT ECLIPSE WAS REPLACED AND IS CURRENTLY QUARANTINED. THE COMPANY HAS MADE SEVERAL ATTEMPTS TO CONTACT THE PROVIDER AND LEFT VOICEMAILS WITH NO RETURNED RESPONSE ON (B)(6), 2012, AT 8:50 AM, AND ON (B)(6), 2012, AT 10:40 AM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE OXYGEN CONCENTRATOR PORTABLE OXYGEN GENERATOR CAW CAIRE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization