BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLEEPWEAVER ADVANCE NASAL CPAP MASK

    MDR report key: 2612861 · Received June 6, 2012

    Report

    Report Number
    3006182632-2012-00001
    Event Type
    Injury
    Date Received
    June 6, 2012
    Date of Event
    May 3, 2012
    Report Date
    May 7, 2012
    Manufacturer
    CIRCADIANCE LLC
    Product Code
    BZD
    PMA / PMN Number
    K092362
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR EVALUATED THE DEVICE AND WAS UNABLE TO DETECT EVIDENCE THAT THE PRODUCT WAS OUT OF SPECIFICATION. NO VISUAL ARTIFACT WAS OBSERVED ON THE DEVICE TO SUGGEST ANY CONTAMINATION. THE SLEEPWEAVER MASK HAS BEEN SOLD SINCE 2008, WITHOUT REPORTED OCCURRENCE OF A SIMILAR EVENT. ADDITIONALLY, (B)(4) MASKS FROM THIS LOT OF (B)(4) HAVE BEEN SOLD. IT IS ESTIMATED THAT (B)(4) OF THIS LOT HAVE BEEN USED BY PTS. A CLINICAL REVIEW OF THE EVENT WAS PERFORMED. ALTHOUGH THE CUSTOMER ALLEGEDLY HAD A REACTION AFTER WEARING THE SLEEPWEAVER ADVANCE, IT IS UNLIKELY THAT THE REACTION WAS CAUSED BY THE SLEEPWEAVER DUE TO THE FOLLOWING: THE PT WAS FITTED WITH AND USED THE MASK FOR APPROX. 30-60 SECONDS AT 1:00 PM WITHOUT ANY REACTION OR COMPLAINT OF COUGHING OR OTHER SYMPTOMS OF IRRITATION. APPROX. 10 HOURS LATER, AT 11:00 PM, THE PT USED THE SLEEPWEAVER FOR 4-5 BREATHS WHICH WOULD BE A SHORTER TIME SPAN THAN THE INITIAL TRIAL OF THE MASK THAT OCCURRED EARLIER IN THE DAY. IF THE SLEEPWEAVER WAS THE PRIMARY CAUSE OF THE REPORTED IRRITATION/REACTION, IT WOULD HAVE LIKELY OCCURRED THE FIRST TIME IT WAS WORN DUE TO THE LONGER TIME OF USAGE. BASED ON OUR EXPERIENCE, THIS TYPE OF REACTION IS UNCOMMON FOR THE SLEEPWEAVER. THE MFR CONCLUDES THAT NO FAILURE WAS DETECTED AND THE PRODUCT REMAINED WITHIN SPECIFICATION. THE MFR IS UNABLE TO DETERMINE A LINK BETWEEN THE ALLEGED EVENT AND THE DEVICE. THIS IS BEING CONSIDERED AN ISOLATED EVENT.

    Description of Event or Problem · 1

    THE PT ALLEGED THAT UPON BRIEF USE OF THE SLEEPWEAVER ADVANCE MASK, HIS THROAT BURNED AND HE WAS COUGHING, WHICH RESULTED IN HOSPITALIZATION. PT HAD BLOOD WORK DRAWN, AN ECG, AND A CHEST X-RAY WAS OBTAINED. THE HOSPITAL WAS UNABLE TO DETERMINE THE CAUSE OF THE EVENT, RESULTING IN TREATMENT WITH STEROIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLEEPWEAVER ADVANCE NASAL CPAP MASK NASAL CPAP MASK BZD CIRCADIANCE LLC 100274 1141

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization PACEMAKER| LISINOPRIL| TERAZOSIN