BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERATOR, OXYGEN, PORTABLE

    MDR report key: 1935516 · Received November 10, 2010

    Report

    Report Number
    1040777-2010-00005
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 11, 2010
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CAW
    PMA / PMN Number
    K972614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A PORTABLE OXYGEN CONCENTRATOR POWER CORD WAS EMITTING SMOKE AND SPARKS. THE POWER CORD WAS RETURNED TO THE MFR AND WAS VISUALLY INSPECTED. THE POWER CORD HAD EVIDENCE OF PHYSICAL AND THERMAL DAMAGE. THERE WAS NO REPORT OF PT HARM OR INJURY. THE MFR IS CURRENTLY INVESTIGATING THIS ISSUE AND A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENERATOR, OXYGEN, PORTABLE MILLENNIUM 600 W/O OPI CAW RESPIRONICS, INC. M600

    Patients

    Seq Age Sex Outcome Treatment
    1