BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 21364196 · Received February 12, 2025

    Report

    Report Number
    1220648-2025-26110
    Event Type
    Malfunction
    Date Received
    February 12, 2025
    Date of Event
    January 24, 2025
    Report Date
    March 14, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502010961
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION AUTOMATED IMPELLA CONTROLLER (AIC) - SHUTDOWN OR RESTART ISSUE HAS BEEN COMPLETED. ON 24-JAN-2025 WHILE BOOTING UP THE CONSOLE, THERE WAS FAILED OSSI (OPTICAL) PROCESS TRIGGERING A PARTIAL RESET OF THE SOFTWARE (SW) WATCHDOG. THE CONSOLE REBOOTED BUT AGAIN HAD FAILED OSSI TRIGGERING ANOTHER PARTIAL RESET. AGAIN THE OSSI PROCESS TRIGGERED THE SW WATCHDOG BUT SINCE THIS WAS THE THIRD WATCHDOG TRIGGER, A FULL RESET WAS INITIATED (BY DESIGN). THE CONSOLE THEN BOOTED UP AS EXPECTED AND TRIGGERED AN UNEXPECTED CONTROLLER SHUTDOWN ALARM DESCRIPTIVE OF THE PREVIOUS WATCHDOG REBOOTS. THE CONSOLE WAS RETURNED FOR INVESTIGATION AND WAS POWER CYCLED TWENTY TIMES. THE FIRST FAILED BOOT UP DURING TESTING WAS FROM A QNX PROCESS FAILURE THAT LEADS TO ALL PROCESSES FAILING AND THE CONSOLE AUTOMATICALLY REBOOTING. THE SECOND FAILURE WAS A VARIETY OF DIFFERENT COMMUNICATIONS FAILING TRIGGERING A REBOOT. THE 4-IN-1 WAS REPLACED WITH A KNOWN GOOD AND THE CONSOLE WAS ABLE TO POWER CYCLE 20 TIMES AS EXPECTED. THE CONSOLE WAS UNEXPECTEDLY REBOOTING DUE TO A DEFECTIVE 4-IN-1. D.9 DATE DEVICE RETURNED /INFORMATION WAS ADDED. D.5 REVISED OPERATOR OF DEVICE AS IT WAS INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26110. E.4 SHOULD HAVE BEEN LEFT BLANK ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26110 AS IT IS UNKNOWN IF THE INITIAL REPORTER ALSO SENT THE REPORT TO THE FOOD AND DRUG ADMINISTRATION.

    Additional Manufacturer Narrative · 0

    PATIENT-SPECIFIC INFORMATION IS UNAVAILABLE AT THE TIME OF THIS MDR WRITING; THEREFORE, RESPECTIVE FIELDS REFLECT "UNKNOWN" OR LEFT BLANK ACCORDINGLY. THE AUTOMATED IMPELLA CONTROLLER WAS NOT RECEIVED FROM THE CUSTOMER AT THE TIME OF THIS MDR WRITING, AND THEREFORE, AN EVALUATION OF THE DEVICE WAS NOT POSSIBLE. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED WHEN THE AUTOMATED IMPELLA CONTROLLER (AIC) WAS STARTED, AN UNEXPECTED SHUTDOWN MESSAGE WAS DISPLAYED. CONSEQUENTLY, THE AIC WAS NOT USED. THERE WAS NO REPORT OR INDICATION OF PATIENT HARM OR DELAY IN SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966192 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1337492 00813502010961

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown