BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACHIEVA PLUS, PSO2 JAPANESE

    MDR report key: 2012215 · Received February 1, 2011

    Report

    Report Number
    8020893-2011-00049
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 6, 2011
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    CBK
    PMA / PMN Number
    K990177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NELLCOR PURITAN BENNETT RECEIVED INFO STATING, "NOISE OCCURRED FROM THE UNIT, THEN THE UNIT SUDDENLY MADE A SETTING ERROR ALARM AND STOPPED CYCLING." THE PT WAS NOT HARMED OR INJURED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACHIEVA PLUS, PSO2 JAPANESE VENTILATOR CBK NELLCOR PURITAN BENNETT ACHIEVA

    Patients

    Seq Age Sex Outcome Treatment
    1