BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    700 SERIES VENTILATOR

    MDR report key: 406326 · Received July 18, 2002

    Report

    Report Number
    8020893-2002-00183
    Event Type
    Malfunction
    Date Received
    July 18, 2002
    Date of Event
    March 9, 2002
    Report Date
    July 18, 2002
    Manufacturer
    NELLCOR PURITAN BENNETT IRE.
    Product Code
    CBK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE 760 OPERATING SYSTEM DETECTED THREE SOFTWARE ERRORS WITHIN 24 OPERATING HOURS AND THE VENTILATOR DECLARED A VENT INOP CONDITION, AND OPENED THE SAFETY VALVE AS DESIGNED. THERE WAS NO PT HARM OR CHANGE IN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 700 SERIES VENTILATOR VOLUME MECHANICAL VENTILATOR CBK NELLCOR PURITAN BENNETT IRE. 760 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN