BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA PROSEAL, REU, SIZE 3 (150030)

    MDR report key: 6773190 · Received August 8, 2017

    Report

    Report Number
    9681900-2017-00034
    Event Type
    Malfunction
    Date Received
    August 8, 2017
    Date of Event
    July 6, 2017
    Report Date
    July 20, 2017
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND IT WAS NOTICED THAT THE AIRWAY TUBE WAS LIGHTLY YELLOWISH DUE TO MULTIPLE USES. THERE WAS NO PHYSICAL DAMAGE OBSERVED FROM THE OUTER PROFILE OF THE DEVICE. IT WAS ALSO FOUND THAT THE RED PLUG OPENING WAS BLOCKED BY THE CHECK VALVE. THE DEVICE COULD BE INFLATED AND DEFLATED NORMALLY WITH THE CHECK VALVE. THE CUFF COULD NOT BE DEFLATED WITH THE RED PLUG OPENED. THE FAILURE WAS VERIFIED. THE PROBABLE ROOT CAUSE IS THAT EXCESSIVE FORCE WAS APPLIED TO THE VALVE INSIDE THE BLUE INFLATION BALLOON WHEN INFLATING AND DEFLATING THE DEVICE OVER A PROLONGED PERIOD OF TIME. THE VALVE SUNK FURTHER INTO THE TUBING , WHICH RESULTED IN THE RED PLUG OPENING BEING BLOCKED BY THE VALVE. THE DEVICE IS STILL FUNCTIONAL AND CAN BE INFLATED AND DEFLATED USING THE CHECK VALVE.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THE NURSE FOUND THE CUFF COULD NOT BE DEFLATED. ALLEGED MALFUNCTION REPORTED AS DETECTED PRIOR TO USE. THERE WAS NO REPORT OF PATIENT HARM. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THE NURSE FOUND THE CUFF COULD NOT BE DEFLATED. ALLEGED MALFUNCTION REPORTED AS DETECTED PRIOR TO USE. THERE WAS NO REPORT OF PATIENT HARM. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555377 LMA PROSEAL, REU, SIZE 3 (150030) LMA PROSEAL CAE TELEFLEX MEDICAL 8WRABRHU

    Patients

    Seq Age Sex Outcome Treatment
    1