BEUDAMED
    FDA Adverse Event Death Summary report: N

    MOBILAIRE LOX

    MDR report key: 319921 · Received March 8, 2001

    Report

    Report Number
    1525712-2001-00035
    Event Type
    Death
    Date Received
    March 8, 2001
    Report Date
    March 5, 2001
    Manufacturer
    INVACARE CORPORATION
    Product Code
    CAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MANUFACTURER RECEIVED A REPORT FROM A DEALER ALLEGING THE UNIT WAS BEING USED BY AN ELDERLY PT WHO LATER PASSED AWAY. UNCLEAR AS TO WHAT ROLE, IF ANY, THE DEVICE PLAYED IN THE REPORTED DEATH. THE DEALER WILL NOT PROVIDE SPECIFICS OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9889 MOBILAIRE LOX PORTABLE OXYGEN GENERATOR CAW INVACARE CORPORATION LIQUID OXYGEN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death