BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEART CONTINUOUS NEBULIZER

    MDR report key: 1013090 · Received March 11, 2008

    Report

    Report Number
    MW5005861
    Event Type
    Injury
    Date Received
    March 11, 2008
    Date of Event
    February 23, 2008
    Report Date
    March 11, 2008
    Manufacturer
    WESTMED
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE MORNING ASSESSMENT -0715- THE PATIENT WAS NOTED TO BE IN INCREASING LEVELS OF RESPIRATORY DISTRESS. THE PT HAD BEEN RECEIVING CONTINUOUS ALBUTEROL NEBULIZED TREATMENT AT THE TIME OF THE EXAMINATION. AROUND 1025, THE PT REQUIRED EMERGENCY INTUBATION AND TRANSFER TO THE CCU. AT THIS TIME IT WAS NOTED THAT THE CONTINUOUS NEBULIZER WAS NOT OPERATING PROPERLY. THE DEVICE WAS NOT PROVIDING NEBULIZED MEDICATION TO THE PT. ACCORDING TO THE RESPIRATORY CARE PRACTITIONER, THE AIR-OXYGEN INLET NUT THAT CONNECTS THE AIR-OXYGEN SOURCE TO THE NEBULIZER CANNISTER COULD NOT BE TIGHTENED AND AIR LEAKED OUT TO THE ENVIRONMENT FAILING TO NEBULIZE THE MEDICATION. THE DEVICE WAS SEQUESTERED FOR FURTHER REVIEW. THE PATIENT RECOVERED FROM THE EVENT AND WAS DISCHARGED FROM THE HOSP IN 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART CONTINUOUS NEBULIZER HEART NEBULIZER CAF WESTMED 100609

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Disability