BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIONAIRE

    MDR report key: 2854561 · Received November 29, 2012

    Report

    Report Number
    1319044-2012-00018
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 3, 2012
    Report Date
    November 29, 2012
    Manufacturer
    AIRSEP CORP.
    Product Code
    CAW
    PMA / PMN Number
    K872534
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS MELTING IN THE AREA OF THE ON/OFF POWER SWITCH INDICATING THE HEAT/BURNING ORIGINATED THERE. THE BURNING IS NEAR THE BOTTOM OUTSIDE OF THE SWITCH IS EXPOSED TO FLUID, MOST LIKELY WHILE CLEANING THE DEVICE. THE MANUAL WARNS AGAINST USING LIQUIDS DIRECTLY ON THE DEVICE.

    Description of Event or Problem · 1

    VISIONAIRE OXYGEN CONCENTRATOR STARTING BURNING AROUND ON/OFF SWITCH AREA, POWER WAS DISCONNECTED, AND WATER POURED OVER SWITCH AREA. NO PATIENT INJURY OR PROPERTY DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIONAIRE OXYGEN CONCENTRATOR CAW AIRSEP CORP. AS098-5

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention