BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3242253 · Received July 16, 2013

    Report

    Report Number
    3242253
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    July 15, 2013
    Report Date
    July 16, 2013
    Manufacturer
    REMINGTON MEDICAL, INC
    Product Code
    DSA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHEN PATIENT RETURNED FROM SURGERY CARDIOLOGIST ATTEMPTED TO CONNECT PACER WIRES TO PACER AND WAS UNABLE TO DO SO.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?YES.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330298 * CABLE, TRANSDUCER, AND ELECTRODE DSA REMINGTON MEDICAL, INC * 130605

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR