BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONESTEP PEDIATRIC ELECTRODES

    MDR report key: 6292254 · Received February 1, 2017

    Report

    Report Number
    6292254
    Event Type
    Malfunction
    Date Received
    February 1, 2017
    Date of Event
    January 12, 2017
    Report Date
    January 18, 2017
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CODE WAS CALLED ON PATIENT IN AFTERNOON. WHEN I ARRIVED, I PLACED THE ZOLL PADS ON THE PATIENT WHO WAS ALREADY RECEIVING COMPRESSIONS. ONCE I CONNECTED THE PADS TO THE DEFIBRILLATOR. I NOTICED IT WAS NOT READING A DEPTH OR A RATE OF COMPRESSIONS. I LET THE FELLOW AND ATTENDING KNOW. THEY SAID OK, WE HAVE A PULSE WITH COMPRESSIONS WILL HAVE TO GO OFF OF THAT. THE PATIENT CODED AGAIN 30 MINUTES LATER. THE SAME PADS WERE STILL ON THE PATIENT, SO I CONNECTED THEM TO THE SAME DEFIBRILLATOR AND THIS TIME IT WAS READING A DEPTH AND RATE. THE ONLY DIFFERENCE I OBSERVED WAS THAT THE FIRST NURSE WAS USING THE ENCIRCLING TECHNIQUE FOR COMPRESSIONS AND THE SECOND TIME, WHICH WAS A DIFFERENT NURSE, WAS USING THE ONE HAND TECHNIQUE. MANUFACTURER RESPONSE FOR MULTIFUNCTION ELECTRODE TO USE WITH THE ZOLL DEFIBRILLATOR, ONE STEP PEDIATRIC CPR (PER SITE REPORTER): LOCAL REP HAS BEEN NOTIFIED WITH EMAIL "1/48/2017."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77281 ONESTEP PEDIATRIC ELECTRODES AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ ZOLL MEDICAL CORPORATION NOT KNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1