BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSENCE COMPRESSOR

    MDR report key: 3760877 · Received April 4, 2014

    Report

    Report Number
    9681154-2014-00005
    Event Type
    Injury
    Date Received
    April 4, 2014
    Date of Event
    March 10, 2014
    Report Date
    March 10, 2014
    Manufacturer
    RESPIRATORY DRUG DELIVERY GROUP (UK) LTD.
    Product Code
    CAF
    PMA / PMN Number
    K042655
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED IN THIS INSTANCE. DEVICE INSTRUCTIONS FOR USE WAS REVIEWED AND CLEARLY STATES THAT THE FILTER IS TO BE REPLACED. THERE WAS NO SIGNIFICANT PATIENT HARM AND IS CONSIDERED AS PATIENT MISUSE. MANUFACTURER CONCLUDES THAT DEVICE INSTRUCTIONS ARE ADEQUATE AND THERE WILL BE NO FURTHER F/U REPORTING.

    Description of Event or Problem · 1

    THE MANUFACTURER REC'D INFO THAT AN INNOSPIRE ESSENCE NEBULIZER WAS TAKEN TO A LOCAL PHARMACY BY THE CARE GIVER WHERE THE PHARMACIST ATTEMPTED TO ORDER A REPLACEMENT NEBULIZER KIT. THE PHARMACIST WAS ADVISED BY A PHILIPS CUSTOMER SERVICE REPRESENTATIVE TO ORDER A REPLACEMENT THROUGH THEIR WHOLESALER, THEREAFTER THE PHARMACIST ALLEGEDLY CLEANED THE FILTER WITH AN ALCOHOL BASED SOLUTION, THIS ACTION WAS NOT ADVISED BY THE PHILIPS CUSTOMER SERVICES REPRESENTATIVE. THE PATIENT THEN REC'D TREATMENT FROM THIS DEVICE AND ALLEGEDLY SUFFERED FROM MINOR SYMPTOMS SUCH AS FEVER AND COUGHING. IT WAS LATER CONFIRMED THAT THERE WAS NO FURTHER PATIENT HARM DURING THIS EVENT. NO PERMANENT INJURY OR PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203739 ESSENCE COMPRESSOR COMPRESSOR, AIR, PORTABLE CAF RESPIRATORY DRUG DELIVERY GROUP (UK) LTD. 1095060 130117

    Patients

    Seq Age Sex Outcome Treatment
    1