BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    700 SERIES VENTILATOR

    MDR report key: 410261 · Received August 12, 2002

    Report

    Report Number
    8020893-2002-00196
    Event Type
    Malfunction
    Date Received
    August 12, 2002
    Report Date
    August 5, 2002
    Manufacturer
    NELLCOR PURITAN BENNETT IRE.
    Product Code
    CBK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    WHILE IN PATIENT USE, THE 760 OPERATING ERROR LOGGED THREE SOFT SYSTEM RESETS WITHIN A 24 HOUR PERIOD AND DECLARED AN ALARMED FOR VENT INOP CONDITION AS DESIGNED. THERE WAS NO CHANGE IN PATIENT CLINICAL THERAPY. THE CSE WAS UNABLE TO DUPLICATE THE EVENT AND THERE WERE NO PARTS REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN