BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACHIEVA VENTILATOR

    MDR report key: 3921653 · Received May 29, 2014

    Report

    Report Number
    8020893-2014-01294
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Report Date
    April 30, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K990177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION UNAVAILABLE AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE USA STATING THAT THE EXTERNAL ALARM ON AN ACHIEVA VENTILATOR WOULD NOT ACTIVATE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE MALFUNCTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316240 ACHIEVA VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND ACHIEVA

    Patients

    Seq Age Sex Outcome Treatment
    1