BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONESTEP

    MDR report key: 17610334 · Received August 24, 2023

    Report

    Report Number
    17610334
    Event Type
    Malfunction
    Date Received
    August 24, 2023
    Date of Event
    July 24, 2023
    Report Date
    July 26, 2023
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    LIX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT VT ARRESTED. ZOLL ECG PADS PLACED ON PATIENT. FEMALE PATIENT, GOOD CONTACT. PADS READ "POOR PAD CONTACT." UNABLE TO DELIVER SHOCK. REPLACED WITH NEW SET AND SHOCKS DELIVERS. DELAY IN IMMEDIATE SHOCK. UPON EVALUATION BACK, PAD 1 HAD POOR WIRE INTEGRITY. SENT TO BIO ENGINEERING AND WIRE WAS BROKE. UPON TESTING BIO ENGINEERING FOUND ANOTHER SET OF ECG PADS WITH SAME ERROR. OUTSIDE PACKAGING NOT AVAILABLE ON SET USED ON PATIENT. INFORMATION AVAILABLE ON TESTED SET. LOT 3922A REF 8900-0224-01.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301948 ONESTEP AID, CARDIOPULMONARY RESUSCITATION LIX ZOLL MEDICAL CORPORATION 8900-0224-01 3922A

    Patients

    Seq Age Sex Outcome Treatment
    1 8760 DA Female