BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONESTEP CPR COMPLETE

    MDR report key: 2492879 · Received March 8, 2012

    Report

    Report Number
    MW5024602
    Event Type
    Injury
    Date Received
    March 8, 2012
    Date of Event
    February 25, 2012
    Report Date
    March 8, 2012
    Manufacturer
    ZOLL MEDICAL CORP
    Product Code
    MKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED TO HOSP WITH ZOLL ONE STEP CPR COMPLETE PAD (BY EMS) IN PLACE FOR MONITORING/PACING (1650). UPON REMOVAL OF THE ZOLL ONE STEP CPR COMPLETE PAD, NOTICED FULL-THICKNESS, DIME-SIZED BURN ON THE CHEST. DATES OF USE: (B)(6) 2012. REASON FOR USE: BRADYCARDIA, ACUTE MYOCARDIAL INFARCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONESTEP CPR COMPLETE RESUSCITATION ELECTRODE MKJ ZOLL MEDICAL CORP 8900-0214-01 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization