BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARRX

    MDR report key: 16378250 · Received February 15, 2023

    Report

    Report Number
    16378250
    Event Type
    Malfunction
    Date Received
    February 15, 2023
    Date of Event
    January 18, 2023
    Report Date
    January 31, 2023
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS HERE FOR A HALO RADIOFREQUENCY ABLATION. PATIENT BROUGHT BACK TO PROCEDURE ROOM, WENT TO ABLATE, AND AN "E93 ERROR" OCCURRED ON THE MONITOR. REPRESENTATIVE STATED ERROR WAS A LOW OUTPUT/BAD CORD CONNECTION. NO WIRES BENT INSIDE THE CABLE. THE HALO PROCEDURE WAS ABORTED. PATIENT BROUGHT BACK TO HIS ROOM. ADDITIONAL INFO FROM INCIDENT REPORT: MANUFACTURER PART NUMBER (REF 64082; REF 90-9100; 90-9100; 90-9200; 90-9100) LOT# (TYPE UNKNOWN IF UNAVAILABLE) B000002046, B000001940, B000001827. F2514413XB000002001.

    Description of Event or Problem · 0

    PATIENT WAS HERE FOR A HALO RADIOFREQUENCY ABLATION. PATIENT BROUGHT BACK TO PROCEDURE ROOM, WENT TO ABLATE, AND AN "E93 ERROR" OCCURRED ON THE MONITOR. REPRESENTATIVE STATED ERROR WAS A LOW OUTPUT/BAD CORD CONNECTION. NO WIRES BENT INSIDE THE CABLE. THE HALO PROCEDURE WAS ABORTED. PATIENT BROUGHT BACK TO HIS ROOM. ADDITIONAL INFO FROM INCIDENT REPORT: MANUFACTURER PART NUMBER (B)(4) LOT# (TYPE UNKNOWN IF UNAVAILABLE) B000002046, B000001940, B000001827. F2514413XB000002001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1125908 BARRX ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES GEI COVIDIEN LP 90-9100

    Patients

    Seq Age Sex Outcome Treatment
    1 13870 DA Male