BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 21423229 · Received February 20, 2025

    Report

    Report Number
    1220648-2025-26229
    Event Type
    Malfunction
    Date Received
    February 20, 2025
    Date of Event
    January 29, 2025
    Report Date
    March 7, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502010022
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE CONSOLE (AIC) SELF CHECK ISSUE HAS BEEN COMPLETED. DATA LOGS WERE REVIEWED. DURING INITIAL BOOT UP, THE CONSOLE RESTARTED AUTOMATICALLY DUE TO A PMD COMMUNICATION ISSUE. DUE TO A PERSISTENT PMD COMMUNICATION ISSUE, THE CONSOLE REBOOTED SEVERAL TIMES AND DISPLAYED ¿SYSTEM SELF CHECK FAILED.¿ UPON MANUAL SHUTDOWN AND REBOOT, THE CONSOLE REBOOTED AGAIN DUE TO THE PMD COMMUNICATION ISSUE AND DISPLAYED ¿SYSTEM SELF CHECK FAILED¿. THIS CONFIRMS THE REPORTED FAILURE MODE. CONSOLE WAS RETURNED FOR EVALUATION AND DURING TESTING, REPRODUCED THE REPORTED FAILURE MODE. DURING THE INITIAL BOOT-UP, THE CONSOLE RESTARTED AUTOMATICALLY DUE TO THE PMD COMMUNICATION ISSUE, RESULTING IN THE ¿SYSTEM SELF CHECK FAILED¿ SCREEN. THE FWCHECK VIA TELNET CONFIRMED THE PROBLEM WAS DUE TO THE IMPELLATRONIC PCA BOARD, AS THE HW REVISION WAS N.A. FOR THE SAU_MOTOR_1. IT WAS IDENTIFIED THAT THE FIRMWARE WAS CORRUPTED UPON COMPARING THE EXTRACTED FIRMWARE WITH A KNOWN GOOD. THE ROOT CAUSE FOR THE ¿SYSTEM SELF CHECK FAILURE¿ WAS CORRUPTED FIRMWARE ON THE IMPELLATRONIC PCA BOARD.

    Additional Manufacturer Narrative · 0

    THE CONSOLE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MANUFACTURER DEVICE REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE USER FACILITY BIOMEDICAL ENGINEER REPORTED AN AUTOMATED IMPELLA CONTROLLER (AIC) DISPLAYED A SYSTEM SELF CHECK ERROR AT START UP. THE EVENT WAS NOTED TO HAVE OCCURRED IN USE IN THE CATHETERIZATION LAB BUT NOT RELATED TO A CLINICAL PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONALLY, THERE WAS NO REPORT OR INDICATION OF DELAY IN THERAPY SUPPORT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407467 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1127440 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown