BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT

    MDR report key: 462179 · Received May 23, 2003

    Report

    Report Number
    MW1028493
    Event Type
    Malfunction
    Date Received
    May 23, 2003
    Date of Event
    March 24, 2003
    Report Date
    May 19, 2003
    Manufacturer
    ABBOTT CRITICAL CARE
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORT SENT TO BIOMED DEPT. PCA PUMP #151816 RUNS AT FIRST, THEN AFTER ONE HOUR STOPS. SCREEN READS OCCLUSION AND STOPS RUNNING. LIGHT STAYS ON. WHEN PUSHES ON BLACK PLUNGER, PUMP RESETS AND STARTS TO WORK. FOUND 50 MALF. 1A ON MALFUNCTION LOG. SENT FOR SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT PCA PUMP PLUS II MEA ABBOTT CRITICAL CARE 4100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other