BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACHIEVA PLUS

    MDR report key: 2971146 · Received February 1, 2013

    Report

    Report Number
    8020893-2013-00266
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 11, 2013
    Manufacturer
    COVIDIEN, FORMERLY NELLCO
    Product Code
    CBK
    PMA / PMN Number
    K990177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ACHIEVA VENTILATOR STOPPED CYCLING WHILE IN USE ON A PT. THE PT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT. THE EVALUATION IS STILL ONGOING A FOLLOW UP MDR WILL BE FILED ONCE THE EVALUATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45405 ACHIEVA PLUS VENTILATOR CONTINUOUS CBK COVIDIEN, FORMERLY NELLCO ACHIEVA

    Patients

    Seq Age Sex Outcome Treatment
    1