BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA PROSEAL, REU, SIZE 4

    MDR report key: 6184221 · Received December 17, 2016

    Report

    Report Number
    9681900-2016-00060
    Event Type
    Malfunction
    Date Received
    December 17, 2016
    Date of Event
    November 9, 2016
    Report Date
    December 12, 2016
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    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. DEVICE WAS USED AND NOT IN THE ORIGINAL TELEFLEX LMA PACKAGING. THE CONNECTOR WAS OBSERVED TO BE BROKEN. THE DEVICE COULD BE INFLATED AND DEFLATED SMOOTHLY (HOLDING AIR AS INTENDED). THE DEVICE WAS TESTED IN THE WATER AND THERE WAS NO LEAK OBSERVED. THE CONNECTOR RETURNED BROKEN FROM THE JOINT OF THE AIRWAY WAS MOST LIKELY DUE TO SUDDEN ABRUPT FORCE BEING APPLIED WHEN REMOVING THE CONNECTOR. THE REPORTED DEFECT OF A LEAKING MASK WAS UNCONFIRMED AS THE DEVICE COULD BE INFLATED AND DEFLATED AS INTENDED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS:THE CUSTOMER ALLEGES THE MASK WAS LEAKING AFTER INSERTION.THERE WAS NO PATIENT HARM REPORTED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THE MASK WAS LEAKING AFTER INSERTION. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834683 LMA PROSEAL, REU, SIZE 4 LARYNGEAL MASK AIRWAY CAE TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1