BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA PROSEAL, REU, SIZE 3 (150030)

    MDR report key: 7621637 · Received June 20, 2018

    Report

    Report Number
    9681900-2018-00029
    Event Type
    Malfunction
    Date Received
    June 20, 2018
    Date of Event
    March 20, 2018
    Report Date
    June 5, 2018
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAE
    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. A VISUAL EXAM WAS PERFORMED AND NO DEFECTS WERE OBSERVED. THE DEVICE COULD BE INFLATED AND DEFLATED NORMALLY. DEFLATION WAS OBSERVED TO BE SLIGHTLY SLUGGISH WHEN THE RED PLUG WAS OPENED; HOWEVER, BY A SLIGHT PINCH ON THE SIDES OF THE RED PLUG, THE DEFLATION IMPROVED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND THERE WERE NO ISSUES FOUND THAT COULD RELATE TO THE REPORTED COMPLAINT. BASED ON THE INVESTIGATION PERFORMED, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THE DEVICE WAS FOUND TO BE FUNCTIONAL AND COULD BE INFLATED AND DEFLATED USING THE CHECK VALVE; HOWEVER, DEFLATION WAS SLUGGISH WITH THE RED PLUG OPEN. THIS COULD BE DUE TO INEVITABLE EXPANSION AND CONTRACTION OF THE COMPONENTS MATERIAL DURING LOGISTICS MOVEMENT OVER TIME.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT ALLEGES THE DEVICE WILL NOT DEFLATE PROPERLY. ALLEGED MALFUNCTION REPORTED AS OCCURRED DURING FUNCTIONAL TESTING PRIOR TO A PATIENT USE. THERE WAS NO REPORT OF PATIENT IMPACT OR CONSEQUENCE. THE PATIENT CONDITION WAS REPORTED AS "FINE".

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THE DEVICE WILL NOT DEFLATE PROPERLY. ALLEGED MALFUNCTION REPORTED AS OCCURRED DURING FUNCTIONAL TESTING PRIOR TO A PATIENT USE. THERE WAS NO REPORT OF PATIENT IMPACT OR CONSEQUENCE. THE PATIENT CONDITION WAS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464884 LMA PROSEAL, REU, SIZE 3 (150030) AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY CAE TELEFLEX MEDICAL KFAAY6

    Patients

    Seq Age Sex Outcome Treatment
    1