BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACHIEVA PLUS, PSO2 ENG N. AMER

    MDR report key: 917156 · Received September 21, 2007

    Report

    Report Number
    8020893-2007-00447
    Event Type
    Malfunction
    Date Received
    September 21, 2007
    Date of Event
    February 1, 2004
    Report Date
    September 21, 2007
    Manufacturer
    GALWAY (RC)
    Product Code
    CBK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NPB NOT AUTHORIZED TO SERVICE UNIT. CUSTOMER REPORTS AT THE TIME OF EVENT, THE UNIT WAS CHECKED BY CUSTOMER BIOMEDICAL ENGINEER AND UNIT FUNCTIONED AS DESIGNED. NO PROBLEM COULD BE DUPLICATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT IN FEBRUARY 2004 THE PATIENT BELIEVES VENTILATOR WENT INTO STAND BY MODE BY ITSELF AND THAT VENTILATION STOPPED BRIEFLY. NO PATIENT HARM. IT WAS REPORTED THAT RT WAS IN THE ROOM AT THE TIME. USER ERROR MAY HAVE CONTRIBUTED TO REPORTED PROBLEM. SERIAL NUMBER IS UNKNOWN. NFB NOT AUTHORIZED TO SERVICE UNIT. CUSTOMER HAS NO FURTHER DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACHIEVA PLUS, PSO2 ENG N. AMER VENTILATOR CBK GALWAY (RC) ACHIEVA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR