BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA CLASSIC, REU, SIZE 3 (100030)

    MDR report key: 9038704 · Received September 13, 2019

    Report

    Report Number
    9681900-2019-00038
    Event Type
    Malfunction
    Date Received
    September 13, 2019
    Date of Event
    August 18, 2019
    Report Date
    August 21, 2019
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND THE AIRWAY TUBE LOOKS LIGHTLY YELLOWISH DUE TO MULTIPLE USES. THE CHECK VALVE WAS INSPECTED AND IT WAS FUNCTIONING PROPERLY. THIS MEANS AIR CAN BE BLOWN IN AND REMOVED FROM THE DEVICE SMOOTHLY WITH A SYRINGE AND NO BLOCKAGE WAS DETECTED. WHEN THE DEVICE WAS INFLATED WITH BOTH 1X AND 1.5X THE RECOMMENDED AIR VOLUME, NO ISSUES WERE DETECTED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. BASED ON THE INVESTIGATION PERFORMED, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THERE WERE NO ISSUES FOUND WITH THE RETURNED DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED HERNIATION OF THE CUFF DURING USE. THE PATIENT CONDITION WAS REPORTED AS "FINE". NO INTERVENTION OR PATIENT HARM WAS REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HERNIATION OF THE CUFF DURING USE. THE PATIENT CONDITION WAS REPORTED AS "FINE". NO INTERVENTION OR PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813677 LMA CLASSIC, REU, SIZE 3 (100030) AIRWAY, OROPHARYNGEAL, ANESTHE CAE TELEFLEX MEDICAL 82SAEVPX

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE REPORTED.| NONE REPORTED.