BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACHIEVA PLUS, PSO2 JAPANESE

    MDR report key: 2062404 · Received March 18, 2011

    Report

    Report Number
    8020893-2011-00125
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    November 18, 2010
    Report Date
    November 24, 2010
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    CBK
    PMA / PMN Number
    K990177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    NELLCOR PURITAN BENNETT RECEIVED INFORMATION STATING, "WHILE CLEANING INSIDE PATIENT'S MOUTH, DOCTOR FOUND THAT THE DEVICE STOPPED CYCLING. AFTER REBOOTED, IT RESUMED WORKING." THE PATIENT 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, PSO2 JAPANESE VENTILATOR CBK NELLCOR PURITAN BENNETT ACHIEVA

    Patients

    Seq Age Sex Outcome Treatment
    1