BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    700 SERIES VENTILATOR

    MDR report key: 356520 · Received October 17, 2001

    Report

    Report Number
    8020893-2001-00013
    Event Type
    Malfunction
    Date Received
    October 17, 2001
    Date of Event
    September 16, 2001
    Report Date
    October 17, 2001
    Manufacturer
    NELLCOR PURITAN BENNETT IRE.
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A FACILITY REPORTED TO TYCO HEALTHCARE IN 2001 THAT A PATIENT WHO WAS LOCATED ON A STEP DOWN UNIT ON AN ACUTE CARE PATIENT FLOOR, AND ON A 760 VENTILATOR INTERFACED WITH THE FACILITY NURSE CALL SYSTEM WAS REPORTED TO HAVE HAD A CARDIAC ARREST. (NOTE: THE FACILITY POLICY IS TO HAVE ADDITIONAL ALARM SYSTEMS IN PLACE DUE TO THE ENVIRONMENT.) THE STAFF RESPONDED TO THE EVENT BUT IT IS REPORTED THAT THE PATIENT EXPERIENCED "ANOXIA AND BRAIN DEATH". THE REPORT ALSO STATES THAT THE DEVICE WAS ALARMING FOR AN UNSPECIFIED PARAMETER. THE FACILITY EXTERNAL ALARM WAS REPORTED TO NOT BE AUDIBLY ALARMING. THE DEVICE ALARM PARAMETERS WERE LIP AT 10CM. H2O AND HIP AT 60 CM H2O. THE 760 DEVICE WAS TESTED AND FOUND TO BE FUNCTIONING ACCORDING TO SPECIFICATIONS. THE FACILITY STATES THE EVENT WAS "NOT A MACHINE" ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46535 700 SERIES VENTILATOR VOLUME MECHANICAL VENTILATOR CBK NELLCOR PURITAN BENNETT IRE. 760 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening| S