BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA PROSEAL, REU, SIZE 4 (150040)

    MDR report key: 6608946 · Received June 2, 2017

    Report

    Report Number
    9681900-2017-00027
    Event Type
    Malfunction
    Date Received
    June 2, 2017
    Date of Event
    May 22, 2017
    Report Date
    May 23, 2017
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND THERE WERE NO ISSUES FOUND THAT COULD RELATE TO THE REPORTED COMPLAINT. THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND NO ISSUES WERE OBSERVED. THE ACTUAL DEVICE WAS COMPARED TO A RETAINED SAMPLE AT THE MANUFACTURING FACILITY. THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN THE TWO DEVICES. BOTH SAMPLES WERE INFLATED AND DEFLATED AND NO ISSUES WERE IDENTIFIED. BASED ON THE INVESTIGATION PERFORMED, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THERE WERE NO ISSUES FOUND WITH THE RETURNED SAMPLE. THE DEVICE FUNCTIONED AS INTENDED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THAT "AN ANESTHESIOLOGIST PLACED THE #4 LMA IN A PATIENT. HE WAS NOT GETTING A GOOD SEAL AND CONTINUED TO INFLATE. FINALLY HE DECIDED TO TAKE IT OUT AND INTUBATE INSTEAD. WHEN HE DID SO, THE LMA CAME OUT INFLATED IN THE WRONG PLACE." IT WAS REPORTED THAT THE PATIENT WAS SENT HOME IN GOOD CONDITION.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THAT "AN ANESTHESIOLOGIST PLACED THE #4 LMA IN A PATIENT. HE WAS NOT GETTING A GOOD SEAL AND CONTINUED TO INFLATE. FINALLY HE DECIDED TO TAKE IT OUT AND INTUBATE INSTEAD. WHEN HE DID SO, THE LMA CAME OUT INFLATED IN THE WRONG PLACE." IT WAS REPORTED THAT THE PATIENT WAS SENT HOME IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388441 LMA PROSEAL, REU, SIZE 4 (150040) AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY CAE TELEFLEX MEDICAL 8VRAT8HD

    Patients

    Seq Age Sex Outcome Treatment
    1