BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACHIEVA PLUS, BASE JAPANESE

    MDR report key: 2023365 · Received March 16, 2011

    Report

    Report Number
    8020893-2011-00115
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    LSZ
    PMA / PMN Number
    K990177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    NELLCOR PURITAN BENNETT RECEIVED INFORMATION STATING, "THAT CIRCUIT WAS DISENGAGED AND THE PATIENT WAS CYANOSED." THE DEVICE WAS MAKING A LOW PRESSURE ALARM, THE CUSTOMER IS NOT SURE HOW LONG THE ALARM WAS SOUNDING UNTIL THEY FOUND THE PATIENT WITH CYANOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACHIEVA PLUS, BASE JAPANESE VENTILATOR LSZ NELLCOR PURITAN BENNETT ACHIEVA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR