BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD PCA

    MDR report key: 104533 · Received July 10, 1997

    Report

    Report Number
    MW1011675
    Event Type
    Malfunction
    Date Received
    July 10, 1997
    Date of Event
    June 28, 1997
    Report Date
    June 30, 1997
    Manufacturer
    SIMS DELTEC, INC.
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PUMP DISPLAYED "3". UNABLE TO PROGRAM AT LLO OR ANY LEVEL. UNABLE TO SCROLL UP OR DOWN. PUMP WAS SWITCHED OUT & RETURNED TO DISTRIBUTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CADD PCA AMBULATORY PUMP MEA SIMS DELTEC, INC. 5800 *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other