BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR FIT F10 FULL FACE MASK

    MDR report key: 5719861 · Received June 8, 2016

    Report

    Report Number
    MW5062766
    Event Type
    Malfunction
    Date Received
    June 8, 2016
    Date of Event
    June 6, 2016
    Report Date
    June 8, 2016
    Manufacturer
    RESMED
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WORE AN AIR FIT MEDIUM MASK FROM RESMED. WE HAVE TWO DIFFERENT LOT NUMBERS FOR THAT MODEL AND SIZE. I SENT ONE OF EACH TO MICROBIOLOGY. ONE CAME BACK NO GROWTH AFTER FOUR DAYS, BUT THE OTHER ONE (LOT #1143645) CAME BACK GROWTH OF SPHINOMONAS PAUCIMOBILIS (PSEUDOMONAS PAUCIMOBILIS). I HAVE REMOVED THE REMAINING AIR FIT MEDIUM MASKS WITH THAT LOT NUMBER. THIS WAS A VOLUNTARY TEST OF THE MEDICAL DEVICE AND WAS FOUND TO HAVE GROWTH OF SPHINGOMONAS PAUCIMOBILIS (PSEUDOMONAS PAUCIMOBIFIS) ON THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362390 AIR FIT F10 FULL FACE MASK AIR FIT F10 FULL FACE MASK BZD RESMED 63130 1143645

    Patients

    Seq Age Sex Outcome Treatment
    1