BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLUME VENTILATOR

    MDR report key: 1203144 · Received October 17, 2008

    Report

    Report Number
    8020893-2008-00543
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 15, 2008
    Report Date
    September 23, 2008
    Manufacturer
    NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT FAILED TO CYCLE WHILE IN USE ON A PATIENT. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOLUME VENTILATOR VENTILATOR CBK NELLCOR PURITAN BENNETT IRELAND ACHIEVA

    Patients

    Seq Age Sex Outcome Treatment
    1