BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT COMPANION V1 MULTI-PORT CONNECTOR

    MDR report key: 9726439 · Received February 18, 2020

    Report

    Report Number
    9726439
    Event Type
    Injury
    Date Received
    February 18, 2020
    Date of Event
    January 20, 2020
    Report Date
    January 30, 2020
    Manufacturer
    TZ MEDICAL
    Product Code
    DSA
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT PRESENTED FOR REPEAT ABLATION. CARDIOVERSION USING ZOLL UNSUCCESSFUL THEREFORE BOOKER BOX EMPLOYED FOR INTERNAL CARDIOVERSION. THE PT DEVELOPED VENTRICULAR FIBRILLATION REQUIRING BRIEF CPR AND VASOPRESSOR THERAPY. CIRCULATION WAS RESTORED AND THE PT STABILIZED. THE TECH CONTACTED THE MFR REP AND LEARNED THAT LIMB LEADS ARE REQUIRED FOR INTERNAL CARDIOVERSION VIA THE BOOKER BOX. CARDIOVERSION WAS NOT COMPLETE, HOWEVER NSR WAS RESTORED AND THE PT WAS DISCHARGED HOME IN GOOD CONDITION TO BE FOLLOWED BY CARDIOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182047 PATIENT COMPANION V1 MULTI-PORT CONNECTOR BOOKER BOX DSA TZ MEDICAL V1-MPC

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L