BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARYNGEAL MASK AIRWAY

    MDR report key: 103734 · Received July 7, 1997

    Report

    Report Number
    2027158-1997-00021
    Event Type
    Malfunction
    Date Received
    July 7, 1997
    Report Date
    June 11, 1997
    Manufacturer
    THE LARYNGEAL MASK CO.,LTD.
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT THE CONNECTOR BROKE ON AN LMA WHEN THE CRNA TRIED TO HOOK IT UP TO THE ANESTHESIA CIRCUIT. THIS USER FACILITY REPORTED ANOTHER CONNECTOR BREAK AS WELL (MDR 9681900-1997-00021). ALTHOUGH THERE WAS NO PT INJURY, AN MDR IS BEING FILED AS FAILED CONNECTORS COULD THEORETICALLY CAUSE INJURY TO A PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LARYNGEAL MASK AIRWAY OROPHARYNGEAL AIRWAY CAE THE LARYNGEAL MASK CO.,LTD. STANDARD NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN