BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIDESTREAM PLUS NEBULIZER

    MDR report key: 2624735 · Received November 24, 2009

    Report

    Report Number
    2243193-2009-00001
    Event Type
    Other
    Date Received
    November 24, 2009
    Date of Event
    October 29, 2009
    Report Date
    November 23, 2009
    Manufacturer
    RESPIRONICS NEW JERSEY, INC.
    Product Code
    CAF
    PMA / PMN Number
    K062689
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT ALLEGED THAT DEVICE WAS MISSING THE SMALL PLASTIC BAFFLE COMPONENT AND THAT RENDERED THE DEVICE INACTIVE. THERE IS 100% INSPECTION TESTING OF THIS PRODUCT IN PRODUCTION FOR THE PRESENCE OF ALL COMPONENTS. EXAMINATION OF EXISTING INVENTORY (INCLUDING THE LOT OF THE PRODUCT IN QUESTION) FOUND NO PRODUCT WITH SIMILAR DEFECTS. PRODUCTION TEST VALIDATION WAS ALSO VERIFIED.

    Description of Event or Problem · 1

    THE PATIENT ALLEGES THAT A COMPONENT (THE BAFFLE) OF THE NEBULIZER WAS MISSING FROM THE PRODUCT AND THAT, AS A RESULT, SHE COULD NOT TAKER HER NEBULIZER TREATMENT AND NEEDED TO BE TREATED AT THE EMERGENCY ROOM. SHE WAS TREATED AT THE EMERGENCY ROOM AND RELEASE WITH NO FURTHER PROBLEMS. NO OTHER REPORTS OF SIMILAR ISSUE HAVE BEEN RECEIVED AND THERE WILL BE CONTINUED MONITORING OF COMPLAINTS FOR THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIDESTREAM PLUS NEBULIZER NEBULIZER CAF RESPIRONICS NEW JERSEY, INC. NA 081125

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention