BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONESTEP

    MDR report key: 9763888 · Received February 27, 2020

    Report

    Report Number
    9763888
    Event Type
    Malfunction
    Date Received
    February 27, 2020
    Date of Event
    January 17, 2020
    Report Date
    January 17, 2020
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONE-STEP CPR COMPLETE ADULT ELECTRODES FOR THE ZOLL DEFIBRILLATOR HAD A MALFUNCTION. WHEN WE PLUGGED THE PADS IN, THEY READ "DEFIB PAD SHORT". WHEN A NEW ONE WAS TRIED IT WORKED JUST FINE. THE MALFUNCTIONING DEFIB PAD LOT# 1219C REF 8900-0224-01. THIS OCCURRED WITH 2 PACKAGES WITH THIS SAME LOT NUMBER.

    Description of Event or Problem · 1

    ONE-STEP CPR COMPLETE ADULT ELECTRODES FOR THE ZOLL DEFIBRILLATOR HAD A MALFUNCTION. WHEN WE PLUGGED THE PADS IN, THEY READ "DEFIB PAD SHORT". WHEN A NEW ONE WAS TRIED IT WORKED JUST FINE. THE MALFUNCTIONING DEFIB PAD LOT# 1219C, REF 8900-0224-01. THIS OCCURRED WITH 2 PACKAGES WITH THIS SAME LOT NUMBER..

    Description of Event or Problem · 1

    ONE-STEP CPR COMPLETE ADULT ELECTRODES FOR THE ZOLL DEFIBRILLATOR HAD A MALFUNCTION. WHEN WE PLUGGED THE PADS IN, THEY READ "DEFIB PAD SHORT". WHEN A NEW ONE WAS TRIED IT WORKED JUST FINE. THE MALFUNCTIONING DEFIB PAD LOT# 1219C, REF 8900-0224-01. THIS OCCURRED WITH 2 PACKAGES WITH THIS SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227503 ONESTEP AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ BIO-DETEK INCORPORATED 8900-0224-01 1219C

    Patients

    Seq Age Sex Outcome Treatment
    1