BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA PROSEAL, REU, SIZE 3 (150030)

    MDR report key: 7295691 · Received February 26, 2018

    Report

    Report Number
    9681900-2018-00016
    Event Type
    Malfunction
    Date Received
    February 26, 2018
    Date of Event
    January 19, 2018
    Report Date
    February 2, 2018
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAE
    PMA / PMN Number
    K780900
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. THE DEVICE COULD BE INFLATED NORMALLY WITH THE CHECK VALVE. THE CUFF COULD NOT BE INFLATED WHEN THE RED PLUG WAS OPENED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND THERE WERE NO ISSUES FOUND THAT COULD RELATE TO THE REPORTED COMPLAINT. THE OPENING OF THE RED PLUG WAS BLOCKED BY THE VALVE HENCE THE CUFF COULD NOT BE DEFLATED EVEN WHEN THE RED PLUG WAS OPENED. THE MOST PROBABLE ROOT CAUSE IS THAT EXCESSIVE FORCE WAS APPLIED TO THE VALVE INSIDE THE BLUE INFLATION BALLOON WHEN INFLATING OR DEFLATING THE DEVICE. THE VALVE HAD SUNK FURTHER INTO THE TUBING WHICH RESULTED IN THE RED PLUG OPENING BEING BLOCKED BY THE VALVE. NONETHELESS, THE DEVICE IS STILL FUNCTIONAL AND CAN STILL BE INFLATED AND DEFLATED USING THE CHECK VALVE.

    Description of Event or Problem · 0

    CUSTOMER ALLEGES THE CUFF DOES NOT INFLATE. ALLEGED DEFECT REPORTED AS "FOUND AT THE PRE-USE INSPECTION". CUSTOMER REPORTS THE DEVICE WAS "NOT CLINICALLY USED, MEANING NO PATIENT AFFECTED FROM THIS COMPLAINT."

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE INVOLVED IN THIS COMPLAINT HAS NOT BEEN RETURNED AT THE TIME OF THIS REPORT. THE INVESTIGATION INTO THIS COMPLAINT IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES THE CUFF DOES NOT INFLATE. ALLEGED DEFECT REPORTED AS "FOUND AT THE PRE-USE INSPECTION". CUSTOMER REPORTS THE DEVICE WAS "NOT CLINICALLY USED, MEANING NO PATIENT AFFECTED FROM THIS COMPLAINT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139242 LMA PROSEAL, REU, SIZE 3 (150030) AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY CAE TELEFLEX MEDICAL 8WRABLRH

    Patients

    Seq Age Sex Outcome Treatment
    1