BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCA AND AMBULATORY PUMP

    MDR report key: 16240 · Received September 19, 1994

    Report

    Report Number
    MW1003427
    Event Type
    Malfunction
    Date Received
    September 19, 1994
    Date of Event
    August 23, 1994
    Report Date
    August 24, 1994
    Manufacturer
    C R BARD, INC.
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PT CONTROLLER PUMPS. LIQUID QUARTZ DISPLAY (LCD). THE ALPHANUMERIC SEGMENTS ARE STARTING TO FAIL. A TOTAL OF SIX UNITS HAVE HAD SEGMENT FAILURES. THIS COULD GIVE A MISREADING TO THE MEDICAL STAFF ON DOSAGE. ALSO SEE #1003428.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA AND AMBULATORY PUMP PCA AND AMBULATORY PUMP MEA C R BARD, INC. 6464202

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other MFR NOTIFIED, PARTS BEING SHIPPED AND UNITS BEING| REPAIRED.