BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYGEN & AEROSOL THERAPY

    MDR report key: 3915351 · Received May 28, 2014

    Report

    Report Number
    9680866-2014-00004
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    August 15, 2011
    Report Date
    August 29, 2011
    Manufacturer
    UNOMEDICAL S.A. DE C.V.
    Product Code
    CAF
    PMA / PMN Number
    K791536
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. AN INVESTIGATION WAS PERFORMED BY QUALITY CONTROL DEPARTMENT ON 10/14/2011 BASED ON THE EVALUATION OF TWO (2) RETURNED SAMPLES INDICATING THAT THE PRODUCT DELIVERED MEDICINE GASES AS IT SHOULD; HOWEVER THE DELIVERED GASES AT 6 LPM DID NOT MEET THE MINIMUM AEROSOL OUTPUT REQUIREMENTS. THE PRODUCT WORKS PROPERLY AT 10 LPM. A 3-YEARS HISTORICAL REVIEW OF COMPLAINTS INDICATED THAT THE OCCURRENCE OF THIS TYPE OF FAILURES IS EXTREMELY LOW (¿ 0.17/500K); THEREFORE IT IS CONSIDERED AN ISOLATED QUALITY PROBLEM. THE CAUSE OF FUNCTIONAL FAILURE IN THE NEBULIZER WAS PROPERLY DETERMINED AND ADDRESSED PREVIOUSLY UNDER A CORRECTIVE ACTION PREVENTIVE ACTION EVENT; THEREFORE NO MORE ACTIONS ARE RECOMMENDED. IN CONCLUSION, THE RECOMMENDATION IS TO KEEP TRACKING THE COMPLAINTS TREND TO VERIFY EFFECTIVENESS OF ACTIONS DOCUMENTED UNDER THE DOCUMENTED CAPA EVENT. NOTE: THIS MDR IS BEING REPORTED AS A RESULT OF A RETROSPECTIVE REVIEW OF COMPLAINT RECORDS CONDUCTED BY CONVATEC FOR COMPLAINTS RECEIVED FROM MAY 1, 2011 - SEPTEMBER 30, 2013. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S. COMPLAINT HANDLING AND CAPA PROCEDURES.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PRODUCT IS NOT ALLOWING ANY LIQUID TO COME OUT (PRODUCT NOT MISTING). THE CUSTOMER STATED THAT THE PRODUCT HAD BEEN IN USE WITH AN EMERGENCY ROOM (ER) PATIENT, AND THAT TREATMENT WAS DELAYED AS THEY HAD TO FIND A WORKING NEBULIZER RESULTING IN NO INJURY TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312528 OXYGEN & AEROSOL THERAPY NEBULIZER (DIRECT PATIENT INTERFACE0 CAF UNOMEDICAL S.A. DE C.V. 9776-E 11/21

    Patients

    Seq Age Sex Outcome Treatment
    1