BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT

    MDR report key: 486406 · Received September 11, 2003

    Report

    Report Number
    MW1029525
    Event Type
    Malfunction
    Date Received
    September 11, 2003
    Date of Event
    August 19, 2003
    Report Date
    September 10, 2003
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE DOOR OF THE PCA INFUSION PUMP WAS BROKEN. WHEN LOOKED AT THE OTHER UNITS OF THE SAME MODEL, AN EARLY OCCURRENCE OF THE BREAKAGE WITH CRACKS WAS NOTED. EVEN THE NEW UNITS HAVE BUBBLES. MANUFACTURER WAS CONTACTED AND SAID WILL EVALUATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT PCA INFUSION PUMP MEA ABBOTT LABORATORIES PCA 3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA