BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPIRONICS COMFORTCLASSIC MEDIUM CPAP MASK

    MDR report key: 4758687 · Received May 5, 2015

    Report

    Report Number
    MW5042567
    Event Type
    Injury
    Date Received
    May 5, 2015
    Date of Event
    April 25, 2015
    Report Date
    May 5, 2015
    Manufacturer
    RESPIRONICS
    Product Code
    NHJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SUDDENLY DEVELOPED SEVERE SHORTNESS OF BREATH AND CHEST PAIN ON (B)(6) 2015 WHILE USING RESPIRONICS COMFORTCLASSIC MEDIUM CPAP MASK (PRODUCT NO. (B)(4), LOT NO. 140408). EVALUATED IN EMERGENCY ROOM (B)(6) 2015, AND FOUND TO HAVE RIGHT LUNG TENSION PNEUMOTHORAX ON CHEST X-RAY. IMMEDIATELY HAD RIGHT SIDED THORACOSTOMY WITH PLACEMENT OF CHEST TUBE UNDER VACUUM AND ADMITTED TO HOSPITAL. CHEST TUBE WAS REMOVED ON (B)(6) 2015 AND DISCHARGED FROM HOSPITAL ON (B)(6) 2015. AFTER DISCHARGE FROM HOSPITAL, CPAP MASK WAS CLOSELY EXAMINED AND WAS FOUND TO HAVE AN ALMOST COMPLETELY OCCLUDED EXHALATION PORT. THIS WAS CONFIRMED BY BEING UNABLE TO SLIP A PIECE OF PAPER INTO THE EXHALATION PORT. COMPARISON TO A DIFFERENT, OLD RESPIRONICS COMFORTCLASSIC MEDIUM CPAP MASK USING THE SAME PIECE OF PAPER SHOWED THAT THE OLD MASK HAD A PATENT EXHALATION PORT, UNLIKE THE MASK THAT IS SUSPECTED TO HAVE CAUSED THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294360 RESPIRONICS COMFORTCLASSIC MEDIUM CPAP MASK RESPIRONICS COMFORTCLASSIC MEDIUM CPAP MASK NHJ RESPIRONICS 1007964 140408

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R| S RTC MEDS: CPAP AND TUBING WITH RESPIRONICS| COMFORTCLASSIC MEDIUM CPAP MASK.