BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA PROSEAL, REU, SIZE 5

    MDR report key: 5107744 · Received September 28, 2015

    Report

    Report Number
    9681900-2015-00052
    Event Type
    Malfunction
    Date Received
    September 28, 2015
    Date of Event
    September 22, 2015
    Report Date
    September 23, 2015
    Manufacturer
    THE LARYNGEAL MASK COMPANY
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND THERE WERE NO ISSUES FOUND THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE. ALL PROCESSES WERE EXECUTED ACCORDING TO THE STANDARD OPERATING METHODS. A SAMPLE WAS RECEIVED AND OBSERVED TO HAVE A CLEAR CONNECTOR. THE CUFF WAS VISIBLY RUPTURED ON ONE SIDE APPROXIMATELY 13CM LONG. THE GLUE AT THE CUFF SEAM REMAINED INTACT. THE TORN PORTION OF THE CUFF DID NOT CONNECT WITH THE UNTORN PORTION AND THE MATERIAL WAS OBSERVED TO BE ELONGATED IN SHAPE. THE CUFF PROFILE WAS CONSISTENT WITH EXCESSIVE PRESSURE BEING APPLIED TO THE CUFF. THE CHECK VALVE AND VENT OF THE RED PLUG WERE TESTED AND OBSERVED TO BE FUNCTIONING AS INTENDED. THE AIR WAS INFLATED AND DEFLATED SMOOTHLY AND THERE WAS NO BLOCKAGE OBSERVED. THE REPORTED COMPLAINT WAS CONFIRMED THROUGH VISUAL INSPECTION. (SEE OTHER REMARKS) OTHER REMARKS: CUSTOMER IS KINDLY REMINDED THAT ANY RESIDUAL AIR OR MOISTURE LEFT IN THE CUFF WILL EXPAND AT THE HIGH TEMPERATURE AND LOW PRESSURE OF THE AUTOCLAVE. THIS WILL CAUSE IRREPARABLE DAMAGE TO THE CUFF AND/OR INFLATION BALLOON.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THE CUFF RUPTURED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THE CUFF RUPTURED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639558 LMA PROSEAL, REU, SIZE 5 LARYNGEAL MASK AIRWAY BTR THE LARYNGEAL MASK COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1