BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONESTEP

    MDR report key: 10100932 · Received May 29, 2020

    Report

    Report Number
    10100932
    Event Type
    Malfunction
    Date Received
    May 29, 2020
    Date of Event
    May 20, 2020
    Report Date
    May 21, 2020
    Manufacturer
    BIO-DETEK, INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RN OPENED ZOLL MULTI-FUNCTION ELECTRODE WITH ONESTEP PACING PACKAGE TO REMOVE PADS AND FOUND EXPOSED WIRE HANGING FROM THE BOTTOM OF PAD. THE WIRE DID NOT DETACH FROM THE PAD LIKE IT IS SUPPOSED. EVEN WITH SIGNIFICANT TUGGING ON THE WIRE, IT WOULD NOT DETACH FROM THE PAD. EQUIPMENT WAS REMOVED FROM SERVICE AND NOT USED ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565816 ONESTEP AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ BIO-DETEK, INC. 8900-0224-01 0619A

    Patients

    Seq Age Sex Outcome Treatment
    1