BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURITAN BENNET

    MDR report key: 3820519 · Received May 15, 2014

    Report

    Report Number
    MW5036154
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 14, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE THERAPIST HAD FIRST PRESSED THE 100% 02 BUTTON IN PREPARATION OF SUCTIONING THE PT. PRIOR TO SUCTIONING THE PATIENT THE RT PRESSED THE SILENCE ALARM BUTTON IN ANTICIPATION OF THE HIGH PRESSURE ALARM SOUNDING DURING SUCTIONING. IMMEDIATELY FOLLOWING THE SILENCE ALARM BUTTON BEING ACTIVATED, THE VENT SHUT OFF AND ALL CONTROLS WENT BLANK. THE VENT THEN IMMEDIATELY TURNED BACK ON TO SAME SETTINGS. VENTILATOR IMMEDIATELY REMOVED AND SEQUESTERED WITH LOCK OUT PLACED TO PREVENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289427 PURITAN BENNET VENTILATOR CBK COVIDIEN 760

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR