BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INLINE MDI ADAPTER

    MDR report key: 1751228 · Received July 1, 2010

    Report

    Report Number
    1751228
    Event Type
    Malfunction
    Date Received
    July 1, 2010
    Date of Event
    June 24, 2010
    Report Date
    July 1, 2010
    Manufacturer
    INSTRUMENTATION INDUSTRIES, INC.
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RESPIRATORY THERAPIST OPERATING ADAPTOR (CONNECTED TO VENT). PRESSED DOWN MDI METERED-DOSE INHALER TO ADMINISTER PUFF AND NOTED MDI COUNTER NOT COUNTING DOWN MEDICATION DOSE. HAPPENED MULTIPLE TIMES WHEN USING ADAPTOR. WHEN RESPIRATORY THERAPY MANAGER INVESTIGATED, PROBLEM DID NOT PRESENT ITSELF WHEN NOT USING ADAPTOR (INHALER ALONE). THEREFORE MDI INHALER FUNCTIONING PROPERLY WHEN NOT USED WITH ADAPTOR. UPON FURTHER INVESTIGATION, IT WAS NOTED THAT THE SPEED/PRESSURE APPLIED WHEN PRESSING DOWN MDI AFFECTED THE MDI COUNTDOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT INLINE MDI ADAPTER NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER) CCQ INSTRUMENTATION INDUSTRIES, INC. RTC 24-V *

    Patients

    Seq Age Sex Outcome Treatment
    1 *