BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 22063495 · Received May 21, 2025

    Report

    Report Number
    1220648-2025-28620
    Event Type
    Malfunction
    Date Received
    May 21, 2025
    Date of Event
    April 30, 2025
    Report Date
    June 4, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502010022
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF AUTOMATED IMPELLA CONTROLLER (AIC) - CONTROLLER ERROR (YELLOW ALARM) HAS BEEN COMPLETED. DATA ANALYSIS: THE CASE ASSOCIATED WITH THE REPORTED COMPLAINT WAS STARTED ON 30TH APRIL 2025. AT 16:23:55 ON APRIL 30TH, THE FIRST LOG ENTRIES INDICATING "IMC-KBD ERROR: 0XA4 0X01 0X00" APPEARED, SUGGESTING THAT THE ISSUE OCCURRED DURING THE READING OF THE CHIP ID (READ FAILURE OF CHIP ID). AFTER THIS, THE CONTROLLER ERROR (LOSS OF COMM WITH KEYPAD OR BETWEEN THE KBD AND I2C FOR KBD HW REVISION 1) - ALARM 24 ISSUED. DEVICE ANALYSIS: THE CONSOLE IC2214 WAS SENT BACK TO FIELD SERVICE FOR FURTHER INVESTIGATION AND WAS TESTED. AFTER PERFORMING 100 POWER CYCLES, THE FAILURE COULD NOT BE REPRODUCED. NO DAMAGE WAS FOUND TO THE KEYBOARD OR THE KEYBOARD- 4IN1 CABLE. THE ROOT CAUSE FOR THE CONTROLLER ERROR (LOSS OF COMM WITH KEYPAD OR BETWEEN THE KBD AND I2C FOR KBD HW REVISION 1) - ALARM 24 COULD NOT BE DETERMINED DUE TO THE INABILITY TO REPRODUCE. D6A SHOULD HAVE BEEN LEFT BLANK ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-28620.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON COMPLETION OF OUR ANALYSIS, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE US COMPLAINANT WAS PLACING A 5.5 PUMP FOR SUPPORT WITH AN AUTOMATED IMPELLA CONTROLLER (AIC). THE AIC HAD A ¿CONTROLLER ERROR SWITCH TO BACKUP CONTROLLER.¿ AND WAS REPLACED. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79876 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1127435 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female