BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFECHOICE ACTIVOX

    MDR report key: 6327293 · Received February 13, 2017

    Report

    Report Number
    3008185181-2017-00001
    Event Type
    Malfunction
    Date Received
    February 13, 2017
    Date of Event
    January 17, 2017
    Report Date
    February 13, 2017
    Manufacturer
    INOVA LABS, INC.
    Product Code
    CAW
    PMA / PMN Number
    K113317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PORTABLE OXYGEN CONCENTRATOR SERIAL NUMBER (B)(4) HAD A BURN HOLE THROUGH THE PLASTIC HOUSING EXTERIOR ABOVE THE INTERNAL DC POWER CONNECTOR ON THE PRINTED CIRCUIT BOARD ASSEMBLY (PCBA). A REVIEW OF THE ONBOARD DATA LOG INDICATES THE 19V DC POWER LINE WAS UNRESPONSIVE DAYS BEFORE THE POC ARRIVED FOR EVALUATION. THIS IS ASSUMED TO COINCIDE WITH THE 19V DC POWER MALFUNCTION. A CERAMIC CAPACITOR IS ASSUMED TO HAVE SHORTED CAUSING DAMAGE TO THE 19V DC INPUT PORTION OF THE PCBA AND RESULTED IN THE BURNT WIRE CONNECTOR, SILICONE TUBING BENEATH THE PCBA, FOAM PADDING AND PLASTIC HOUSING. DEVICE WAS STILL FUNCTIONAL ON INTERNAL AND EXTERNAL BATTERY POWER. CARRY CASE AND POWER SUPPLY UNIT WERE NOT RETURNED TO VERIFY IF MISUSE OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ACTIVOX 4L OXYGEN CONCENTRATOR HAD A BURNING SMELL FOLLOWED BY A LARGE BURN MARK ON THE CASE/HOUSING. NO PATIENT INJURY RESULTED FROM THIS EVENT. QUOTE OF EVENT AS RECEIVED: "A BURNING SMELL ISSUED FROM THE MACHINE AND AFTERWARDS A LARGE BURN MARK ON THE OUTER SHELL OF THE MACHINE WAS NOTICED DURING PATIENT USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108750 LIFECHOICE ACTIVOX PORTABLE OXYGEN CONCENTRATOR CAW INOVA LABS, INC. XYC100B-P4L N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other