BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON HIGH CONCENTR. ADULT MASK, ELONGATED

    MDR report key: 3231951 · Received July 15, 2013

    Report

    Report Number
    3004365956-2013-00232
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Date of Event
    May 27, 2013
    Report Date
    June 28, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT WAS PERFORMED ON THE PICTURE PROVIDED BY THE CUSTOMER. HOWEVER, NO ISSUES WERE DETECTED. IN ORDER TO PERFORM A PROPER INVESTIGATION AND DETERMINE ROOT CAUSE AND CORRECTIVE ACTIONS THE SAMPLE INVOLVED IN THE INCIDENT IS REQUIRED. A DIMENSIONAL AND FUNCTIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. THE DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. THE COMPLAINT CANNOT BE CONFIRMED WITH THE INFO PROVIDED. IN ORDER TO PERFORM A PROPER INVESTIGATION TO DETERMINE A CORRECTIVE ACTION, IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED IN THE INCIDENT.

    Description of Event or Problem · 1

    THE COMPLAINT WAS REPORTED AS: THE CUSTOMER ALLEGES THAT THE RESERVOIR BAG DID NOT INFLATE WITH 10L OF AIR FLOW. NO REPORT OF A PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325735 HUDSON HIGH CONCENTR. ADULT MASK, ELONGATED OXYGEN MASK CAI TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1