BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO. MURPHY 8.0MM

    MDR report key: 3823764 · Received February 20, 2014

    Report

    Report Number
    9611710-2014-00037
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    January 11, 2014
    Report Date
    January 24, 2014
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K951696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO PROVIDED THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. IT WAS REPORTED THAT THE DEVICE WAS NOT USED AND THE ISSUE WAS FOUND AT THE CUFF CHECK BEFORE USE. NO ADDITIONAL EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD A SAMPLE OR ADDITIONAL INFO BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    USER REPORTED THEY FOUND IT DIFFICULT TO DEFLATE THE CUFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106696 ENDO. MURPHY 8.0MM TUBE, TRACHEAL (W/WO CONNECTOR) BTR UNOMEDICAL SDN BHD 61110080 614211R001

    Patients

    Seq Age Sex Outcome Treatment
    1