BEUDAMED
    FDA Adverse Event Death Summary report: N

    1710H MEDITRACE 2/PK 20/CA

    MDR report key: 8878277 · Received August 9, 2019

    Report

    Report Number
    9681860-2019-00505
    Event Type
    Death
    Date Received
    August 9, 2019
    Report Date
    August 9, 2019
    Manufacturer
    COVIDIEN
    Product Code
    MKJ
    UDI-DI
    20884527008435
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. IF ADDITIONAL INFORMATION OR THE SAMPLE IS RECEIVED, THE INVESTIGATION WILL BE REOPENED AND RESPONDED TO ACCORDINGLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, A HEALTH CARE PROVIDER ATTEMPTED TO USE A DEFIBRILLATOR PAD WITH THE WRONG AUTOMATIC EXTERNAL DEFIBRILLATOR (AED) MACHINE AND THE PATIENT EXPIRED AS A RESULT. ADDITIONALLY, THE CUSTOMER STATED THE ISSUE WAS USER ERROR AND NOT THE PRODUCT. THE NURSE CONNECTED THE INCORRECT DEFIBRILLATOR PAD TO THE DEFIBRILLATOR. THE PAD WAS CLEARLY MARKED ON THE PACKAGE AND THE NURSE DID NOT SEE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674238 1710H MEDITRACE 2/PK 20/CA AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ COVIDIEN 40000006 20884527008435

    Patients

    Seq Age Sex Outcome Treatment
    1 Death