BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 20598900 · Received November 4, 2024

    Report

    Report Number
    1220648-2024-21851
    Event Type
    Malfunction
    Date Received
    November 4, 2024
    Date of Event
    October 11, 2024
    Report Date
    December 4, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502010022
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE CONSOLE (AIC) SELF CHECK ISSUE HAS BEEN COMPLETED. DATA LOGS WERE REVIEWED WHICH SHOWED THAT INITIAL BOOT UP, THE CONSOLE RESTARTED AUTOMATICALLY DUE TO A PUD COMMUNICATION ISSUE. DUE TO A PERSISTENT PUD 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 PUD COMMUNICATION ISSUE AND DISPLAYED ¿SYSTEM SELF CHECK FAILED¿. THIS CONFIRMS THE REPORTED FAILURE MODE. THIS CONSOLE WAS RETURNED FOR EVALUATION AND THE ISSUE WAS REPRODUCED. DURING THE INITIAL BOOT-UP, THE CONSOLE RESTARTED AUTOMATICALLY DUE TO THE PUD COMMUNICATION ISSUE, RESULTING IN THE ¿SYSTEM SELF CHECK FAILED¿ SCREEN. THE FWCHECK VIA TELNET CONFIRMED THE PROBLEM WAS DUE TO THE PUD BOARD, AS THE HW REVISION WAS N.A. FOR THE SAU_PURGE. IT WAS IDENTIFIED THAT THE FIRMWARE WAS CORRUPTED UPON COMPARING THE EXTRACTED FIRMWARE WITH A KNOWN GOOD (CURROUPTED PUD FW VS KNOWN GOOD.PNG). THE REPORTED FAILURE MODE WAS RESOLVED AFTER RE-FLASHING THE PRODUCTION FIRMWARE. THE ROOT CAUSE FOR THE ¿SYSTEM SELF CHECK FAILURE¿ WAS CORRUPTED FIRMWARE ON THE PUD BOARD.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THE AUTOMATED IMPELLA CONTROLLER (AIC) WAS BEING SERVICED WHEN THERE WAS A"SYSTEM CHECK FAILED ERROR. THE AIC WAS REBOOTED SEVERAL TIMES BEFORE DISPLAYING SYSTEM CHECK FAILED TWICE. NO PATIENT HARM HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2166854 AUTOMATED IMPELLA CONTROLLER CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1210718 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown