BEUDAMED
    FDA Adverse Event Death Summary report: N

    VISIONAIRE

    MDR report key: 2153027 · Received June 28, 2011

    Report

    Report Number
    1319044-2011-00014
    Event Type
    Death
    Date Received
    June 28, 2011
    Date of Event
    February 7, 2011
    Report Date
    June 28, 2011
    Manufacturer
    AIRSEP CORP.
    Product Code
    CAW
    PMA / PMN Number
    K872534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    OXYGEN PROVIDER WAS INFORMED BY NURSING SERVICE THAT A VISIONAIRE OXYGEN CONCENTRATOR USED BY PATIENT WAS SMELLING. OXYGEN PROVIDER ORGANIZED AN EXCHANGE OF THE DEVICE, BUT PATIENT DIED BEFORE THE EXCHANGE TOOK PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIONAIRE OXYGEN CONCENTRATOR CAW AIRSEP CORP. AS098-15

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death