BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEWLIFE

    MDR report key: 2002461 · Received January 28, 2011

    Report

    Report Number
    1319044-2011-00002
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    November 29, 2010
    Report Date
    January 28, 2011
    Manufacturer
    AIRSEP CORP.
    Product Code
    CAW
    PMA / PMN Number
    K872534
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OXYGEN CONCENTRATOR IS BEING HELD IN EVIDENCE FOR EXAMINATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVAL IS COMPLETED.

    Description of Event or Problem · 1

    FIRE ALLEGEDLY INVOLVING AN OXYGEN CONCENTRATOR MFG BY AIRSEP. FIRE DAMAGED IN AREA OF OXYGEN CONCENTRATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEWLIFE OXYGEN CONCENTRATOR CAW AIRSEP CORP. AS005-4

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention