BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONESTEP

    MDR report key: 4202305 · Received October 13, 2014

    Report

    Report Number
    4202305
    Event Type
    Malfunction
    Date Received
    October 13, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 13, 2014
    Manufacturer
    ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS
    Product Code
    MLN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT PRESENTED IN ER WITH 3RD DEGREE HEART BLOCK. ED STAFF PLACED MULTIFUNCTION ONE STEP PADS IN ANTERIOR ANTERIOR POSITION FOR QUICK USE FOR PACING. STAFF ATTEMPTED TO PACE-WOULD NOT CAPTURE. TURNED UP AMPLITUDE TO 84. ADDITIONAL STAFF ENTERED AND IDENTIFIED THAT EKG LEADS NEEDED TO BE PLACED WITH A CERTAIN TYPE OF PAD POSITION, PACING ESTABLISHED. THIS TYPE OF EDUCATION WAS NOT PROVIDED BY ZOLL DURING THEIR INSTALL CONSISTENTLY WITH STAFF. PATIENT ULTIMATELY EXPIRED IN CATH LAB LATER THAT DAY BUT UPON REMOVAL OF PADS, PATIENT SUFFERED 2ND DEGREE BURN UNDERNEATH PADS. CONCERN ABOUT HOW PADS WERE PLACED AS WELL WHICH LED TO INJURY.======================MANUFACTURER RESPONSE FOR ZOLL DEFRIBILLATOR ONE STEP PAD, ZOLL ONE STEP MULTIFUNCTION PAD (PER SITE REPORTER).======================THEY PROVIDED ADDITIONAL TRAINING ON BEST PAD POSITIONING AND HOW TO PLACE PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647440 ONESTEP AUTOMATED EXTERNAL DEFIBRILLATOR MLN ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR