BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASEAL

    MDR report key: 3120503 · Received May 9, 2013

    Report

    Report Number
    9610691-2013-00002
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    AMBU A/S
    Product Code
    BYG
    PMA / PMN Number
    EXMP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FAILURE MODE WAS CONFIRMED UPON INSPECTION OF THE DEVICE IN QUESTION. THE FAILURE MODE IS KNOWN INTERNALLY AND DESCRIBED IN THE PROCESS RISK ANALYSIS RELATED TO THE PRODUCTION PROCEDURES. THE PRODUCTION PROCESS INCLUDES INSPECTION OF THE DEVICE PRIOR TO PACKAGING. THE INSPECTION INCLUDES 100% CHECK OF THE CUFF INTEGRITY, AND SORTING OUT ANY DEVICES WITH AN INSUFFICIENT GLUING BETWEEN CUSHION AND DOME. COMPLAINT TRENDING IN THE PERIOD 2008 TO DATE SHOWED THAT NO COMPLAINT WITH THIS FAILURE MODE WAS FILED IN THE COMPLAINT DATABASE. AS PART OF THE COMPLAINT INVESTIGATION, THE PRODUCT RISK ANALYSIS HAS BEEN REVIEWED AND THE RISK FOR A HAZARDOUS SITUATION TO OCCUR AS A RESULT OF THE REPORTED PROBLEM IS CONCLUDED TO BE ACCEPTABLE LOW. THE CURRENT REPORT DOES NOT RESULT IN A CHANGE OF THIS RISK ASSESSMENT. IN ADDITION AND AS DESCRIBED IN THE INSTRUCTIONS FOR USE. THE PRODUCT SHOULD BE INSPECTED BEFORE USE: "REMOVE MASK FROM PACKAGING AND INSPECT FOR PROPER INFLATION. INSPECT THE CUFF FOR ANY DAMAGE OR LEAKAGE."

    Description of Event or Problem · 1

    THE MASK SPLIT BETWEEN CUSHION AND DOME WHEN BEING USED ON A CHILD. IN CONSEQUENCE HEREOF, THE PT OXYGEN SATURATION LEVEL FELL CAUSING A CHANGE OF MASK AS SOON AS THE STAFF BECAME AWARE OF THE PROBLEM. NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204655 ULTRASEAL FACEMASK BYG AMBU A/S SIZE 3, W.CHECK VALVE 1477877

    Patients

    Seq Age Sex Outcome Treatment
    1 Other