BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA CLASSIC, REU, SIZE 5 (100050)

    MDR report key: 6945753 · Received October 12, 2017

    Report

    Report Number
    9681900-2017-00047
    Event Type
    Malfunction
    Date Received
    October 12, 2017
    Date of Event
    June 26, 2017
    Report Date
    July 24, 2017
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE SERIAL NUMBER REPORTED AND THERE WERE NO ISSUES FOUND THAT COULD RELATE TO THE REPORTED COMPLAINT. THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    (B)(4). TELEFLEX OBTAINED CLARIFICATION OF THE EVENT DATE AND LOT NUMBER/SERIAL NUMBER FROM THE REPORTER. REPORTER STATES THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION.THE INVESTIGATION INTO THIS COMPLAINT IS IN PROGRESS AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES " THE VALVE FOR BALL INSUFFLATION OF THE CLASSIC LARYNGEAL MASK# 5 DOES NOT INFLATE, IT DOES NOT WORK AND HAD TO BE REPLACED." ALLEGED DEFECT REPORTED AS DETECTED PRIOR TO A PATIENT USE. CUSTOMER REPORTS THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES " THE VALVE FOR BALL INSUFFLATION OF THE CLASSIC LARYNGEAL MASK# 5 DOES NOT INFLATE, IT DOES NOT WORK AND HAD TO BE REPLACED." ALLEGED DEFECT REPORTED AS DETECTED PRIOR TO A PATIENT USE. CUSTOMER REPORTS THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724136 LMA CLASSIC, REU, SIZE 5 (100050) AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY CAE TELEFLEX MEDICAL SN:8UQAKGQB

    Patients

    Seq Age Sex Outcome Treatment
    1