BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMINI PC1CE, 220V AUST

    MDR report key: 328684 · Received April 19, 2001

    Report

    Report Number
    2016493-2001-00065
    Event Type
    Malfunction
    Date Received
    April 19, 2001
    Report Date
    April 7, 2001
    Manufacturer
    ALARIS MEDICAL SYSTEMS
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE OCCURRENCE OF 161, 162, AND 163 ERROR CODES INDICATING PUMP MOTOR STALLS HAD OCCURRED DURING CLINICAL USE. WHILE EXACT USE CONDITION ARE NOT AVAILALBE, AND THE DATES OF OCCURRENCE ARE ALSO UNKNOWN, IT IS BELIVED THAT THE EVENT OCCURRED AT FLOW RATES <20ML/HR. THE PTS WERE REPORTEDLY NOT INJURED BY THE EVENTS. THE ALARM SYSTEMS REPORTEDLY FUNCTIONED AS INTENDED, NOTIFYING THE CAREGIVERS OF THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18007 GEMINI PC1CE, 220V AUST INFUSION PUMP/CONTROLLER FRN ALARIS MEDICAL SYSTEMS 1311AX01AA *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN