BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFECHOICE ACTIVOX

    MDR report key: 3187266 · Received June 21, 2013

    Report

    Report Number
    3008185181-2013-00002
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 25, 2013
    Report Date
    June 3, 2013
    Manufacturer
    INOVA LABS, INC.
    Product Code
    CAW
    PMA / PMN Number
    K072688
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESPIRATORY THERAPIST AT (B)(6), TESTED THE UNIT AFTER IT WAS RETURNED AND COULD FIND NO PROBLEM WITH THE UNIT. THIS IS CONSISTENT WITH THE RESULTS OF THE MFR'S EVALUATION.

    Description of Event or Problem · 1

    PATIENT'S NEPHEW RENTED AN ACTIVOX PORTABLE OXYGEN CONCENTRATOR TO TAKE A TRIP TO (B)(6), ON (B)(6) 2013. THE PATIENT NORMALLY USED A STATIONARY UNIT AT 2.5 LPM. THE PATIENT FIRST USED THE ACTIVOX ON THE FLIGHT. WHEN PATIENT'S NEPHEW AWOKE AS THE PLANE WAS LANDING, HE STATED THAT HIS AUNT'S LIPS WERE BLUE AND THE UNIT WAS ALARMING. THE AIRLINE THEN PUT THE PATIENT ON THEIR OXYGEN SYSTEM, AND THE PATIENT WAS TAKEN TO THE HOSPITAL BY AMBULANCE WHEN THE PLANE LANDED. PATIENT WAS DISCHARGED FROM THE HOSPITAL ON 6 LPM. PATIENT'S NEPHEW STATED THAT HE TRIED THE UNIT AGAIN AT THE HOSPITAL AND THAT AFTER A COUPLE OF BREATHS, THE UNIT WOULD STOP DELIVERING OXYGEN. THE PATIENT'S FIRST USE OF THE DEVICE WAS ON THE PLANE. GIVEN THE FINDINGS FROM THE DEVICE EVALUATION (NO PROBLEMS, UNIT WITHIN SPECIFICATION), IT SEEMS LIKELY THAT THE ALARM WAS CAUSED BY A NO BREATH DETECT SITUATION. THE LIFECHOICE ACTIVOX DELIVERS PULSES OF OXYGEN BASED UPON DETECTION OF THE START OF A PATIENT BREATH. NOT ALL PATIENTS ARE SUITABLE FOR THE DEVICE, FOR INSTANCE PATIENTS THAT PARTIALLY OR FULLY BREATHE THROUGH THEIR MOUTH. THE NO BREATH ALARM ACTIVATES AFTER APPROXIMATELY 70 SECONDS OF NO BREATH DETECTION. REGARDING NEPHEW'S STATEMENT THAT THE UNIT WOULD STOP DELIVERING OXYGEN AFTER A COUPLE OF BREATHS, THIS IS CONSISTENT WITH INABILITY OF THE USER TO TRIGGER THE BREATH DETECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283855 LIFECHOICE ACTIVOX CAW INOVA LABS, INC. XYC100B 1402

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R