BEUDAMED
    FDA Adverse Event Death Summary report: N

    VISIONAIRE V

    MDR report key: 3480511 · Received November 8, 2013

    Report

    Report Number
    1319044-2013-00011
    Event Type
    Death
    Date Received
    November 8, 2013
    Date of Event
    November 13, 2011
    Report Date
    November 11, 2013
    Manufacturer
    AIRSEP CORP.
    Product Code
    CAW
    PMA / PMN Number
    K872534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TRYING TO ARRANGE AN EXAMINATION OF THE DEVICE.

    Description of Event or Problem · 1

    RECEIVED A SUMMONS NAMING AIRSEP CORPORATION, CLAIMING: (B)(6) DIED ON (B)(6) 2011, FROM AN ALLEGED MALFUNCTIONING VISIONAIRE V OXYGEN CONCENTRATOR THAT HAD IMPROPER FLOW SETTING AND FLOW RATES. IN (B)(6) 2011, THE UNIT'S ALARM SOUNDED AND LINCARE (HOMECARE PROVIDER) PICKED UP THE UNIT FROM THE HOUSE AND RETURNED IT ON (B)(6) 2011, REPRESENTING THAT THE UNIT HAD BEEN REPAIRED AND WORKING PROPERLY. THE UNIT WAS PRESCRIBED TO HELP WITH COPD AND AS A MEANS OF SURVIVAL. ON (B)(6) 2011, 2 DAYS AFTER BEING PLACED ON THE OXYGEN CONCENTRATOR, (B)(6) TOOK A TURN FOR THE WORSE AND WAS TAKEN TO (B)(6) HOSPITAL WHERE SHE WAS CONFINED TO CRITICAL CARE UNIT AND PLACED ON A VENTILATOR. SHE DIED (B)(6) 2011. THE CAUSE OF DEATH LISTED ON HER CERTIFICATE IS "HYPERCAPNIC RESPIRATORY FAILURE." THE OXYGEN CONCENTRATOR WAS AGAIN INSPECTED AFTER DEATH, AND WHILE THE FLOW RATE ON THE UNIT WAS IN FACT SET AT 2.0 LITER PER MINUTE ("LPM" 0, TESTING REVEALED THAT THE ACTUAL FLOW RATE ON THE UNIT, AS MEASURED WITH A CALIBRATED FLOW TESTER, WAS EQUAL TO OR LESS THAN 0.51 LPM. THE UNIT FAILED THE FLOW VERIFICATION TEST. UNKNOWN IS WHAT REPAIR AND TESTING LINCARE PERFORMED TO THE OXYGENATED CONCENTRATOR, WHO ALSO PERFORMED THE INSPECTION AFTER AT DEATH, AND WHERE THE DEVICE IS PRESENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579064 VISIONAIRE V OXYGEN CONCENTRATOR CAW AIRSEP CORP. AS098-01

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death| H