BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLEEP WEAVER ALL CLOTH NASAL CPAP MASK

    MDR report key: 1462599 · Received August 31, 2009

    Report

    Report Number
    MW5012568
    Event Type
    Malfunction
    Date Received
    August 31, 2009
    Report Date
    August 31, 2009
    Manufacturer
    CIRCADIANCE LLC
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ND, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SLEEP WEAVER ALL CLOTH NASAL CPAP MASK MFG BY CIRCADIANCE LLC. THIS MASK IS NOT A CPAP MASK, A CPAP MASK IS A CLASS II DEVICE THAT MUST MEET PERFORMANCE STANDARDS. THIS MASK IS MADE OF CLOTH. THERE IS NO SEAL TO ACCOMMODATE THE HIGH PRESSURES OF A CPAP. THIS COMPANY IS CURRENTLY SEEKING 510K FROM FDA. DIAGNOSIS OR REASON FOR USE: OBSTRUCTIVE SLEEP APNEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLEEP WEAVER ALL CLOTH NASAL CPAP MASK CPAP MASK BZD CIRCADIANCE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1