BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACHIEVA PLUS

    MDR report key: 2717659 · Received August 24, 2012

    Report

    Report Number
    8020893-2012-00496
    Event Type
    Death
    Date Received
    August 24, 2012
    Date of Event
    July 26, 2012
    Report Date
    August 13, 2012
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K990177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT ITS INVESTIGATION IS COMPLETE BUT THEY HAVE NOT SHARED THE RESULTS WITH COVIDIEN. THE CUSTOMER FURTHER STATED THAT IT WANTS COVIDIEN TO PERFORM AN EVALUATION BUT THEY HAVE NOT YET SENT THE VENTILATOR TO COVIDIEN. ONCE COVIDIEN LEARNS THE RESULTS OF THE CUSTOMER'S EVALUATION OR PERFORMS ITS OWN EVALUATION, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION STATING THAT A HOMECARE PATIENT WAS FOUND DECEASED WHILE USING AN ACHIEVA VENTILATOR. AT THIS TIME IT IS UNCLEAR IF THE VENTILATOR MALFUNCTIONED AS FAMILY MEMBERS ARE PROVIDING CONFLICTING INFORMATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death