BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PC1 INTERNATIONAL ENGLISH

    MDR report key: 328689 · Received April 19, 2001

    Report

    Report Number
    2016493-2001-00061
    Event Type
    Malfunction
    Date Received
    April 19, 2001
    Date of Event
    March 10, 1999
    Report Date
    April 17, 2001
    Manufacturer
    ALARIS MEDICAL SYSTEMS
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 IN 3/1999 AND 05/1999. WHILE EXACT USE CONDITIONS ARE NOT AVAILABLE, IT IS BELIEVED THAT THE EVENT WAS NOTED AT FLOW RATES < 20ML/HR. THE PT 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
    18004 PC1 INTERNATIONAL ENGLISH * FRN ALARIS MEDICAL SYSTEMS 1310CX *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN