BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFECHOICE

    MDR report key: 6182777 · Received December 16, 2016

    Report

    Report Number
    3008185181-2016-00001
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    September 28, 2016
    Report Date
    December 16, 2016
    Manufacturer
    INOVA LABS, INC.
    Product Code
    CAW
    PMA / PMN Number
    K072688
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    INOVA LABS, INC, THE LEGAL MANUFACTURER OF THE LIFECHOICE PORTABLE OXYGEN CONCENTRATOR, PERSONNEL LEARNED ON 18-NOV-2016 THAT RESMED CORPORATE PERSONNEL SUBMITTED MEDWATCH 3004604967-2016-01167 FOR THIS MALFUNCTION. THE SUBMISSION OF 304604967-2016-01167 WAS PERFORMED IN ERROR BY RESMED PERSONNEL. INOVA LABS, INC. IS SUBMITTING THIS MEDWATCH #3008185181-2016-00001 TO PROVIDE CORRECTED INFORMATION ABOUT THIS EVENT AND THE DEVICE MANUFACTURER. (B)(4). THE ROOT CAUSE OF THE MALFUNCTION WAS DETERMINED TO BE A LOW INTERNAL RESISTANCE (NEAR SHORT) IN THE PIN/BARREL JACK OF THE AC/DC POWER SUPPLY ACCESSORY CORD. WEAR AND/OR ABUSE CONTRIBUTED TO THE CONDITION THAT CAUSED THIS MALFUNCTION. THIS REPORT WAS INITIATED AS THE MALFUNCTION, ALBEIT UNLIKELY GIVEN THE SELF-EXTINGUISHING CHARACTERISTICS OF THE DEVICE MATERIAL, COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF IT WERE TO RECUR AND PRODUCE A VISIBLE FLAME. IT IS UNKNOWN IN THIS INCIDENT IF THERE WAS AN ACTUAL FLAME, THUS THIS MALFUNCTION IS BEING REPORTED USING CONSERVATIVE REPORTING PRACTICES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LIFECHOICE OXYGEN CONCENTRATOR POWER SUPPLY CAUGHT FIRE. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THIS EVENT. NO DAMAGE TO PERSON OR PROPERTY WAS REPORTED AS A RESULT OF THIS EVENT. QUOTE OF EVENT AS RECEIVED: "CAUGHT ON FIRE. THE CHARGER PLUGGED IN AND THE WIRE CAUGHT FIRE. NO INJURY, NO DAMAGES OCCURRED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830982 LIFECHOICE PORTABLE OXYGEN CONCENTRATOR CAW INOVA LABS, INC. XYC100 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1