BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACHIEVA PLUS

    MDR report key: 2470693 · Received February 24, 2012

    Report

    Report Number
    8020893-2012-00070
    Event Type
    Other
    Date Received
    February 24, 2012
    Date of Event
    January 30, 2012
    Report Date
    February 1, 2012
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN
    Product Code
    CBK
    PMA / PMN Number
    K99017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL ONGOING. A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFO STATING, "VENTILATOR WAS ALARMING WHILE IN PT USE." ALLEGEDLY THE NURSE TRIED TO SILENCE THE ALARM BUT MIGHT HAVE ACCIDENTALLY STOPPED THE VENTILATOR. THE PT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACHIEVA PLUS VENTILATOR CONTINUOUS CBK COVIDIEN, FORMERLY NELLCOR PURITAN ACHIEVA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other