BEUDAMED
    FDA Adverse Event Other Summary report: N

    INSPIRATION ELITE W/2 SIDESTREAM NEBULIZERS

    MDR report key: 1710462 · Received June 3, 2010

    Report

    Report Number
    2243193-2010-00002
    Event Type
    Other
    Date Received
    June 3, 2010
    Date of Event
    April 29, 2010
    Report Date
    May 28, 2010
    Manufacturer
    RESPIRONICS NEW JERSEY, INC.
    Product Code
    BTI
    PMA / PMN Number
    K042655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPRESSOR NEBULIZER SYSTEMS ARE NOT LIFE SUSTAINING DEVICES. THE MOTHER OF THE PATIENT REPORTED THAT SHE HAD OTHER MEANS OF MEDICATION DELIVERY (MDI), BUT DID NOT USE IT. AS THE DEVICE WAS NOT RETURNED, IT IS NOT POSSIBLE TO DIAGNOSE ROOT CAUSE. THERE HAVE BEEN NO OTHER REPORTED EVENTS OF THIS TYPE ASSOCIATED WITH THE PRODUCT INVOLVED IN THIS INCIDENT.

    Description of Event or Problem · 1

    THE PATIENT WAS USING THE INSPIRATION ELITE (HS458) FOR THE FIRST TIME. AFTER 1 HOUR THE MEDICINE REMAINED IN THE NEBULIZER HANDSET. NEBULIZER TREATMENTS NORMALLY TAKE APPROX 8-10 MINUTES. AFTER WAITING ONE HOUR, MOTHER OF THE PATIENT SWITCHED THE PATIENT FROM A MOUTHPIECE TO A MASK. THE CHILD HAD TO BE TAKEN BY AMBULANCE TO THE HOSPITAL WHERE HE WAS ADMITTED TO THE ICU. THE CHILD HAS NO LONG-TERM PHYSICAL PROBLEMS AS A RESULT OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSPIRATION ELITE W/2 SIDESTREAM NEBULIZERS COMPRESSOR NEBULIZER SYSTEM BTI RESPIRONICS NEW JERSEY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization| R