BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIUM PLUS DISPOSABLE ANESTHESIA FACE MASK

    MDR report key: 346311 · Received August 8, 2001

    Report

    Report Number
    1044265-2001-00030
    Event Type
    Malfunction
    Date Received
    August 8, 2001
    Date of Event
    July 9, 2001
    Report Date
    July 9, 2001
    Manufacturer
    SIMS PORTEX INC.
    Product Code
    BSJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN ANESTHESIA FACE MASK WAS IN USE WITH A CIRCUIT FOR ANESTHESIA. THE PT EXPERIENCED DIFFICULTY BREATHING AND THE USER ALLEGES THE PROBLEM WAS DETERMINED TO BE A BLOCKED FACE MASK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35845 PREMIUM PLUS DISPOSABLE ANESTHESIA FACE MASK ANESTHESIA FACE MASK BSJ SIMS PORTEX INC. NA BC0053

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO ANESTHESIA CIRCUIT AND MACHINE (2001).