BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLEEPWEAVER CLOTH NASAL CPAP MASK

    MDR report key: 1614854 · Received February 19, 2010

    Report

    Report Number
    MW5014888
    Event Type
    Malfunction
    Date Received
    February 19, 2010
    Date of Event
    February 15, 2010
    Report Date
    February 19, 2010
    Manufacturer
    CIRCADIANCE LLC
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    CPAP MASK DID NOT FUNCTION AS INTENDED. PT FELT SHE WAS SUFFOCATING WHILE USING PRODUCT AS INTENDED. DEVICE PRESENTED SHARP EDGES - PER (B) (4) DEFINITION - AROUND SEWING OPERATIONS IN CONTACT WITH NOSE/NASAL PASSAGES. PRODUCT ARRIVED UNBAGGED AND LOOSE IN BOX. DOSE OR AMOUNT: ONE CPAP MASK, FREQUENCY: NIGHTLY, ROUTE: INHALE. DATES OF USE: (B) (6) 2010 - (B) (6) 2010, EIGHT HOURS. DIAGNOSIS OR REASON FOR USE: SLEEP APNEA. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLEEPWEAVER CLOTH NASAL CPAP MASK CPAP BREATHING MASK BZD CIRCADIANCE LLC 100201 000403
    2 SLEEPWEAVER CLOTH NASAL CPAP MASK CPAP BREATHING MASK BZD CIRCADIANCE LLC A7035-6000

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR