BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 2030823 · Received March 23, 2011

    Report

    Report Number
    MW5019931
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 17, 2011
    Manufacturer
    COVIDIEN-NELLCOR AND PURITAN BENNETT
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE RESPIRATORY THERAPIST AND RN WAS OUTSIDE THE PATIENT'S ROOM WHEN THEY HEARD THE VENT ALARMING. IMMEDIATELY THEY WENT INTO THE ROOM, THE VENT ALARM READ "VENT INOP" AND THEN TURNED ITSELF OFF. AFTER THE VENT SHUT ITSELF OFF, THEN IT IMMEDIATELY TURNED BACK ON, BUT THE VENT WAS NOT OPERATING PROPERLY. THE VENT STILL WAS FLASHING "VENT INOP" AND WAS INOPERABLE. THE RESPIRATORY THERAPIST MANUALLY BAGGED THE PATIENT UNTIL A REPLACEMENT VENTILATOR WAS BROUGHT IN AND EXCHANGED OUT WITH THE MALFUNCTIONING VENT. THE MALFUNCTIONING VENT WAS A RENTAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 840 VENTILATOR 840 VENTILATOR CBK COVIDIEN-NELLCOR AND PURITAN BENNETT 840 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention