BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R SERIES PLUS

    MDR report key: 3091436 · Received April 22, 2013

    Report

    Report Number
    3091436
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 22, 2013
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A NURSE EDUCATOR WAS PERFORMING A ZOLL DEFIBRILLATOR COMPETENCY CHECKLIST WITH A NEW STAFF NURSE IN THE SIMULATION MODE. WHEN TURNING THE DEVICE ON, A SYSTEM FAULT 36 MESSAGE APPEARED. THE DEFIBRILLATOR ALLOWED THEM TO TEST IT AND SAID READ TEST "OKAY" BUT WHEN USING THE SIMULATOR, THE MESSAGE "USE PADS" APPEARED AND WOULD NOT CLEAR. NEITHER THE AUTOMATED EXTERNAL DEFIBRILLATOR(AED) OR PACEMAKER FUNCTION WORKED. OUR BIOMED DEPARTMENT WAS NOTIFIED AND REMOVED THE DEVICE FROM SERVICE. BIOMED REPORTED THAT THE ERROR CODE WAS RELATED TO THE SYSTEM BOARD.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?SIMULATED PRACTICE FOR NEW STAFF RN.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171762 R SERIES PLUS AUTOMATED EXTERNAL DEFIBRILLATORS MKJ ZOLL MEDICAL CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *