BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCA AND AMBULATORY PUMP

    MDR report key: 16241 · Received September 19, 1994

    Report

    Report Number
    MW1003428
    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 1003427.

    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. 6464601R

    Patients

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