BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFECOICE

    MDR report key: 3142473 · Received March 30, 2013

    Report

    Report Number
    3008185181-2013-00001
    Event Type
    Injury
    Date Received
    March 30, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    INOVA LABS
    Product Code
    CAW
    PMA / PMN Number
    K072688
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) SELECTED BECAUSE IT WAS ALLEGED BY THE PT THAT PRODUCT CAUSED STROKE. BASED UPON CONSERVATIVE MEASURES WE ARE REPORTING AN ALLEGED ADVERSE EVENT BECAUSE IT CANNOT BE DETERMINED WITH 100 PERCENT CERTAINTY THAT THE INOVA LABS DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A PRODUCT PROBLEM IS BEING REPORTED BECAUSE BASED UPON THE ALLEGED ADVERSE EVENT IF IT OCCURS AGAIN IT IS PROBABLE THAT IT COULD CAUSE SEVERE INJURY. IN SUBSEQUENT COMMUNICATION THE PT INDICATED THAT THE ALLEGED STROKE LIKELY OCCURRED IN (B)(6) FOLLOWING HIS RETURN FROM (B)(6). THIS CONTRADICTS THE ORIGINAL COMPLAINT STATEMENT. DURING A SUBSEQUENT MEETING BETWEEN AN INOVA LABS REPRESENTATIVE, THE PT, AND THE PT'S WIFE, THEY REITERATED THAT THE STROKE MOST LIKELY IS A SECONDARY SYMPTOMS OF A CARDIAC ABNORMALITY. THE LIFECHOICE PRODUCT IS A PULSE-MODE DEVICE.

    Description of Event or Problem · 1

    PT REPORTED THAT LIFECHOICE FAILED ON A FLIGHT FROM (B)(6) TO (B)(6) AND THAT PT'S OXYGEN SATURATION DROPPED TO 64%. PATIENT STATED THAT HE SUSPECTS LIFECHOICE CAUSED STROKE DURING TRIP. PT STATED THAT A CEREBRAL INCIDENT WAS IDENTIFIED THROUGH TESTING. LOCATION AND DATE OF TESTING UNK. PT INDICATED HE WAS 43% LUNG CAPACITY. PT STATED THAT HIS DOCTOR PRESCRIBED CONTINUOUS FLOW THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131226 LIFECOICE PORTABLE OXYGEN CONCENTRATOR CAW INOVA LABS XYC100 WO1049

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other