BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERFORMATRAK DISPOSABLE MASK

    MDR report key: 3000349 · Received February 5, 2013

    Report

    Report Number
    2518422-2013-00186
    Event Type
    Other
    Date Received
    February 5, 2013
    Date of Event
    October 30, 2012
    Report Date
    January 7, 2013
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K002465
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A FACILITY ALLEGES THAT A PLASTIC RING FROM A PERFORMATRAK FULL FACE MASK WAS FOUND IN A PATIENT'S LARYNX DURING AN INTUBATION PROCEDURE. UPON REMOVAL OF THE RING, THEY ALLEGE THE PATIENT NO LONGER REQUIRED INTUBATION. THE MASK HAS BEEN DISCARDED BY THE REPORTING FACILITY. HOWEVER, THE FACILITY STILL MAINTAINS THE PLASTIC RING IN THEIR POSSESSION AND HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER WILL FILE A FOLLOW UP REPORT WHEN THE INVESTIGATION IS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48031 PERFORMATRAK DISPOSABLE MASK SPECTRUM 2 FULL FACE MASK BZD RESPIRONICS, INC. 1012624 120801

    Patients

    Seq Age Sex Outcome Treatment
    1 Other