BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEAR-VUE MASK, SIZ 5, MEDIUM ADULT

    MDR report key: 581428 · Received March 2, 2005

    Report

    Report Number
    9680866-2005-00002
    Event Type
    Malfunction
    Date Received
    March 2, 2005
    Date of Event
    February 7, 2005
    Report Date
    March 1, 2005
    Manufacturer
    UNOMEDICAL INC.
    Product Code
    BSJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN FEBRUARY 2005, AN E-MAIL FROM QAULITY ASSURANCE AND REGULATORY AFFAIR MANAGER FOR UNOMEDICAL WAS SENT TO QUALITY CONTROL DEPARTMENT REPORTING A VIGILANCE REPORT ISSUED BY QUALITY & REGULATORY AFFAIR MANAGER. IT WAS OBSERVED THAT THE DISPOSABLE MASKS FOR VENTILATION WERE DEFECTIVE, THE PAD WAS NOT INFLATED. THE PROBLEM WAS IDENTIFIED WHEN VENTILATING A PATIENT WHO HAD HAD A CARDIAC & RESPIRATORY ARREST. 3 MASKS WERE FOUND FAULTY FOR THE FIRST INCIDENT AT THE TIME OF AN EMERGENCY VENTILATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEAR-VUE MASK, SIZ 5, MEDIUM ADULT ANESTHESIA MASK BSJ UNOMEDICAL INC. 46578 04-02 & 04-04

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other