BEUDAMED
    FDA Adverse Event Other Summary report: N

    VENTILATOR

    MDR report key: 512253 · Received February 20, 2004

    Report

    Report Number
    512253
    Event Type
    Other
    Date Received
    February 20, 2004
    Date of Event
    October 1, 2003
    Report Date
    December 1, 2003
    Manufacturer
    PURITAN-BENNETT CORP
    Product Code
    CBK
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE VENT [VENTILATOR] SUDDENLY GAVE THE PT 71 BREATHS/MIN [MINUTE] AND BECAME STUCK AT THAT RATE. THE PT WAS TAKEN OFF THE VENT AND BAGGED WITH AN AMBU [BAG] AND O2 [OXYGEN] BY THE RN [REGISTERED NURSE], WHILE THE RESPIRATORY TECH [TECHNICIAN] CHECKED THE SETTINGS AND CIRCUIT. SHE CHANGED THE MODES AND SHUT THE VENT ON AND OFF TO ATTEMPT TO CORRECT THE PROBLEM. THE ERROR OCCURRED IN ALL THE MODES OF THE VENT. THE SUPERVISOR WAS CALLED AND RECHECKED THE VENT. EVERYONE WAS UNABLE TO CORRECT THE PROBLEM. THE VENT WAS CHANGED AND THE SAME SETTINGS WERE USE. CMV [CONTINIOUS MANDATORY VENTILATION] 16, 40%, VT [TIDAL VOLUME] 500, AND PEEP [POSITIVE END EXPIRATORY PRESSURE] 5. THE PT MAINTAINED STATS [SATURATIONS] OF 99-1005. THE VENT WAS TAKEN OUT OF SERVICE AND BROUGHT TO BIOMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTILATOR VENTILATOR CBK PURITAN-BENNETT CORP 7200AE *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other PHILIPS MONITORS