BEUDAMED
    FDA Adverse Event Death Summary report: N

    OXYWELL

    MDR report key: 6011702 · Received October 7, 2016

    Report

    Report Number
    3004972304-2016-00031
    Event Type
    Death
    Date Received
    October 7, 2016
    Date of Event
    July 8, 2016
    Report Date
    December 29, 2016
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K120785
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT HAS BEEN REQUESTED TO BE RETURNED FOR INSPECTION. ONCE THE INVESTIGATION HAS BEEN COMPLETED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE UNIT WAS RETURNED TO THE COMPANY AND EVALUATED. THE UNIT PERFORMED TO SPECIFICATIONS. THERE IS NO INDICATION THAT THE UNIT CAUSED THE DEATH OF THE PATIENT.

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED ON (B)(6) 2016 OF AN ADVERSE EVENT THAT OCCURRED AT AN UNKNOWN DATE. THE CUSTOMER CLAIMED THAT THE ECLIPSE BATTERY WOULD NOT CHARGE AND THE ECLIPSE STOPPED PUTTING OUT OXYGEN. THIS ALLEGEDLY CAUSED THE PATEINT TO HAVE A LIFE THREATENING EVENT. THE CUSTOMER WOULD NOT GIVE MORE SPECIFIC INFORMATION ON THE LIFE THREATENING EVENT.

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED ON SEPTEMBER 6, 2016 OF AN ADVERSE EVENT THAT OCCURRED ON (B)(6) 2016 IN (B)(6). A PATIENT WAS USING AN OXYWELL UNIT ON 2LPM WHEN HE PASSED AWAY. JUST BEFORE THE PATIENT DIED, HE WAS SURROUNDED BY FAMILY MEMBERS AND THE UNIT WAS RUNNING NORMALLY. AFTER THE PATIENT'S DEATH, THE DOMESTIC POLICE DEPARTMENT DETERMINED THAT THE OXYWELL HAD NO RELATION TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661674 OXYWELL OXYGEN CONCENTRATOR, PORTABLE CAW CAIRE INC. 4807-C3-SEQ

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L