BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONESTEP

    MDR report key: 4143119 · Received September 30, 2014

    Report

    Report Number
    4143119
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    August 18, 2014
    Report Date
    September 30, 2014
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS IN THE EMERGENCY DEPARTMENT WITH SYMPTOMATIC BRADYCARDIA AND IN 2:1 HEART BLOCK. RN OPENED THE ZOLL ONE STEP PACING PADS AND PRIOR TO APPLICATION, THE NURSE NOTICED THE ANTERIOR PACING PAD #2 (APPLIED UNDER THE LEFT BREAST) HAD ONE OF THE CABLES DETACHED/NOT ATTACHED TO THE PAD. THE CABLE HAD WIRES VISIBLE, WHERE IT INSERTS INTO THE PACING PAD. THE NURSE OPENED ANOTHER PACKAGE OF THE SAME LOT NUMBER AND THE CABLES WERE INTACT, AND CARDIAC RHYTHM RECOGNIZED. PACING PERFORMED WITHOUT SIGNIFICANT DELAY OR ADVERSE EFFECT TO THE PATIENT. THE NEXT DAY THE PATIENT HAD PLACEMENT FOR PERMANENT PACEMAKER. THEY NEEDED TO HAVE THE DEVICE SENT TO THEM FOR QUALITY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608121 ONESTEP AUTOMATE EXTERNAL DEFIBRILLATOR, ELECTRODE MKJ ZOLL MEDICAL CORPORATION 8900-0212-01 4212

    Patients

    Seq Age Sex Outcome Treatment
    1 * CARDIAC DRUGS