BEUDAMED
    FDA Adverse Event Death Summary report: N

    O2 XPRESS

    MDR report key: 3376349 · Received September 16, 2013

    Report

    Report Number
    2921601-2013-00007
    Event Type
    Death
    Date Received
    September 16, 2013
    Date of Event
    September 21, 2011
    Report Date
    August 19, 2013
    Manufacturer
    SALTER LABS
    Product Code
    CAN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    WE HAVE BEEN INFORMED THAT A SALTER LABS 02 XPRESS PNEUMATIC DEMAND OXYGEN CONSERVER MODEL 8511 WAS IN USE WHEN THE DEATH OF A PATIENT OCCURRED. SALTER LABS WAS FIRST CONTACTED BY (B)(6) ATTORNEY ON (B)(6) 2013. SHE IS THE CLAIMS COUNSEL COMPANY FOR A (B)(6) WHO DISTRIBUTED A BACKUP OXYGEN SOURCE THAT INCLUDED THE O2 XPRESS. THE INFORMATION THAT SALTER RECEIVED WAS THAT THERE WAS A POWER FAILURE AT 4:30 PM ON (B)(6) 2011. A FAMILY MEMBER IMMEDIATELY RESPONDED BY PROVIDING THE PATIENT WITH HER BACKUP OXYGEN BOTTLE, BUT "THE OXYGEN WOULD NOT WORK." WHEN UNABLE TO GET THE UNIT TO WORK, ANOTHER FAMILY MEMBER CALLED 911. (B)(6) STATES THAT HER SON, THE PARAMEDIC, NOR SHE COULD GET THE DEVICE TO WORK. CONSEQUENTLY, THE PATIENT DIED IN THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464902 O2 XPRESS XPRESS CAN SALTER LABS 8511

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death