BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT TRACHEOSTOMY MASK

    MDR report key: 10381 · Received December 6, 1993

    Report

    Report Number
    MW1000020
    Event Type
    Malfunction
    Date Received
    December 6, 1993
    Date of Event
    November 15, 1993
    Report Date
    November 23, 1993
    Manufacturer
    HOSPITAK, INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AT LEAST 4 INCIDENTS WHERE TRACHEOSTOMY MASK SNAP CONNECTION (METAL) HAS FAILED. THIS RESULTS IN ONE SMALL PIECE OF THE METAL SNAP CONNECTION APPROX 9 MM IN DIAMETER TO BECOME DETACHED FROM THE TRACHEOSTOMY MASK. THIS PIECE COULD THEN BE ASPIRATED INTO THE PT'S TRACHEAL STOMA. THIS HAS NOT OCCURRED BUT RPTR HAS HAD ONE CLOSE CALL WHERE THE STAFF RESPIRATORY THERAPIST FOUND THE PIECE OF METAL SNAP VERY CLOSE TO THE PT'S STOMA. RPTR HAS SEEN THIS HAPPEN TO ONE UNIT FRESH FROM THE PACKAGE AND HAS QUARENTINED ALL OF THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT TRACHEOSTOMY MASK BTO HOSPITAK, INC. 245 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *