BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST BREATH ADULT VENTURI OXYGEN MASK

    MDR report key: 809118 · Received January 10, 2007

    Report

    Report Number
    9680866-2007-00001
    Event Type
    Malfunction
    Date Received
    January 10, 2007
    Date of Event
    November 21, 2006
    Report Date
    December 21, 2006
    Manufacturer
    UNOMEDICAL, INC.
    Product Code
    BYF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE (1) YELLOW DILUTER (28%) AND ONE (1) WHITE DILUTER (13%) RETURNED WERE VISUALLY EXAMINED AND THE QUALITY PROBLEM WAS CONFIRMED AS VALID. DILUTER HAD A THIN MEMBRANE OF THE SAME PLASTIC MATERIAL COVERING THE ORIFICE OF DILUTER. HOWEVER, WHEN THE DILUTER WAS CONNECTED TO AIR SOURCE AT 4 LPM AND 6 LPM, THE PLASTIC MEMBRANE WAS COMPLETELY REMOVED AND IMMEDIATELY THE OCCLUSION DISAPPEARED. A REVIEW OF OUR CUSTOMER COMPLAINT FILES CONFIRMED THIS TO BE AN INSOLATED QUALITY PROBLEM. STOCKS OF OXYGEN DILUTERS HAVE BEEN RE-INSPECTED AND PROBLEMS OF THIS NATURE HAVE NOT BEEN FOUND. WE HAVE CONCLUDED BASED ON THE INVESTIGATION ABOVE THAT THIS WAS AN ISOLATED QUALITY PROBLEM. THE POSSIBLE ROOT CAUSE WAS DETERMINED AS AN INADEQUATE INSPECTION. TO PREVENT RECURRENCE OF QUALITY PROBLEM REPORTED ABOVE, UNOMEDICAL HAS IMPLEMENTED AS PART OF QUALITY CONTROL PLAN A 100% PHYSICAL INSPECTION CONSISTING OF A MANUAL INSERTION OF APPROPRIATELY- SIZED RODS THROUGH THE HOLE OF ALL DILUTERS. LOT# 05-48 REPORTED WAS MANUFACTURED PRIOR TO THIS 100% INSPECTION. WORK INSTRUCTIONS HAVE BEEN ISSUED TO INSTRUCT OPERATORS IN HOW PERFORM THE INSPECTION. EVEN THOUGH THERE WAS NOT AN ADVERSE EVENT TO THE PATIENT, UNOMEDICAL HAS MADE THE DECISION TO VOLUNTARY SUBMIT AN MDR.

    Description of Event or Problem · 1

    IN 2006 UNOMEDICAL INC. WAS INFORMED ABOUT A DECISION FROM SMITHS MEDICAL TO CLASSIFY AS MDR A COMPLAINT RECEIVED FROM FORIEGN COUNTRY. IN 2006 SMITHS MEDICAL USA WAS NOTIFIED THAT ONE DILUTER WAS FOUND TO BE OCCLUDED AT THE TIME OF USE. DELUTER WAS IMMEDIATELY REPLACED AN NO ADVERSE EVENT TO THE PATIENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRST BREATH ADULT VENTURI OXYGEN MASK 73 BYG MASK, VENTURI BYF UNOMEDICAL, INC. * 05-48/UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other