BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA PROSEAL, REU, SIZE 4 (150040)

    MDR report key: 7276564 · Received February 16, 2018

    Report

    Report Number
    9681900-2018-00014
    Event Type
    Malfunction
    Date Received
    February 16, 2018
    Date of Event
    January 26, 2018
    Report Date
    January 31, 2018
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAE
    PMA / PMN Number
    K780900
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    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 STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THE CUFF WAS DEFORMED. THE SILICONE CUFF MATERIAL OF THE DEVICE LOOKS SAGGED AND LOST ITS RESILIENCE DUE TO STRESS. WHEN COMPARED WITH A RETAINED SAMPLE, THE SHAPE OF THE MATERIAL OF THE RETURNED SAMPLE LOOKED DIFFERENT THAN THE RETAINED SAMPLE. THE CHECKED VALVE OF THE RETURNED DEVICE WAS FUNCTIONAL; IT COULD BE INFLATED AND DEFLATED. IN ADDITION, THE RED PLUG VENT IS FREE FROM BLOCKAGE AND AIR COULD BE RELEASED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND THERE WERE NO ISSUES FOUND. AIR PRESSURE IS A KNOWN CAUSE THAT LEADS TO CUFF HERNIATION/INTERNAL RUPTURE OF COMPONENTS OF THE LMA MASK. DURING HIGH TEMPERATURE, VACUUM, AND HUMID ENVIRONMENT, AND AIR/MOISTURE LEFT INSIDE THE CUFF WILL EXPAND SIGNIFICANTLY AND IT WILL DAMAGE THE PROPERTIES OF THE COMPONENTS TO AN IRREPARABLE CONDITION. IT IS HIGHLY SUSPECTED THAT SOME RESIDUAL AIR/MOISTURE WAS LEFT INSIDE THE DEVICE WHILE HANDLING/REPROCESSING THAT CAUSED THE FAILURE. THE CUFF MUST BE COMPLETELY DEFLATED PRIOR TO AUTOCLAVING.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "LMA CUFF FOUND TO HAVE HERNIATED CUFF DURING PRE-OP INSPECTION." ALLEGED EVENT REPORTED AS OCCURRING PRIOR TO USE ON A PATIENT DURING INSPECTION/FUNCTIONAL TESTING. THERE WAS NO REPORT OF PATIENT INJURY OR CONSEQUENCE.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "LMA CUFF FOUND TO HAVE HERNIATED CUFF DURING PRE-OP INSPECTION." ALLEGED EVENT REPORTED AS OCCURRING PRIOR TO USE ON A PATIENT DURING INSPECTION/FUNCTIONAL TESTING. THERE WAS NO REPORT OF PATIENT INJURY OR CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122115 LMA PROSEAL, REU, SIZE 4 (150040) AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY CAE TELEFLEX MEDICAL SN:8VSAHVL4

    Patients

    Seq Age Sex Outcome Treatment
    1