BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFECHOICE ACTIVOX 4L

    MDR report key: 6730515 · Received July 20, 2017

    Report

    Report Number
    3008185181-2017-00002
    Event Type
    Malfunction
    Date Received
    July 20, 2017
    Date of Event
    June 20, 2017
    Report Date
    November 22, 2017
    Manufacturer
    INOVA LABS, INC.
    Product Code
    CAW
    PMA / PMN Number
    K113317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTIVOX DEVICE WAS RETURNED TO RESMED FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE INVESTIGATION DETERMINED THE ROOT CAUSE TO BE AN ISOLATED COMPONENT WITHIN THE DC INPUT POWER CIRCUIT. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO INOVA/ RESMED FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE INVESTIGATION METHODS, RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. RESMED REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ACTIVOX 4L OXYGEN CONCENTRATOR ALLEGEDLY CAUGHT FIRE WHILE THE DEVICE WAS CHARGING. THE DEVICE WAS NOT IN USE WHEN THE FAULT OCCURRED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510321 LIFECHOICE ACTIVOX 4L PORTABLE OXYGEN CONCENTRATOR CAW INOVA LABS, INC. XYC100B-P4L

    Patients

    Seq Age Sex Outcome Treatment
    1