BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    700 SERIES VENTILATOR

    MDR report key: 406332 · Received July 18, 2002

    Report

    Report Number
    8020893-2002-00179
    Event Type
    Malfunction
    Date Received
    July 18, 2002
    Date of Event
    June 20, 2002
    Report Date
    July 17, 2002
    Manufacturer
    NELLCOR PURITAN BENNETT IRE.
    Product Code
    CBK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    THE VENTILATOR ERRONEOUSLY INTERPRETED A TOTAL LOSS OF POWER AND DID ALARM APPROPRIATELY FOR THE STOP CYCLE EVENT. 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. 740 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN