BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 23087582 · Received September 18, 2025

    Report

    Report Number
    1220648-2025-46591
    Event Type
    Malfunction
    Date Received
    September 18, 2025
    Date of Event
    August 12, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011289
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS BEEN COMPLETED. DATA ANALYSIS: THE COMPLAINT WAS REPORTED ON AUG 12TH, 2025; HOWEVER, ACCORDING TO THE LOGS, THE ISSUE FIRST OCCURRED ON AUG 8TH, 2025. 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.¿ WHEN THE CONSOLE WAS REBOOTED AGAIN ON AUGUST 27TH, 2025, THE ISSUE PERSISTED, AND THE CONSOLE CONTINUED TO DISPLAY "SYSTEM SELF CHECK FAILED" DUE TO THE ONGOING PMD COMMUNICATION ISSUE. THIS CONFIRMS THE REPORTED FAILURE MODE. DEVICE ANALYSIS: THIS CONSOLE WAS TESTED AFTER ARRIVING AND 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. THE ISSUE WAS RESOLVED BY REPLACING THE OLD IMPELLATRONIC PCA WITH A KNOWN GOOD ONE. AFTER THE REPLACEMENT, NO FURTHER ISSUES WERE OBSERVED WITH THE KNOWN GOOD PUMP AND PURGE CASSETTE ATTACHED. FURTHER NO BURNING SMELL OR BURNED COMPONENT WAS NOTICED DURING INVESTIGATION. ROOT CAUSE: THE ROOT CAUSE OF THE "SYSTEM SELF CHECK FAILURE" WAS DETERMINED TO BE A DEFECTIVE IMPELLATRONIC PCA BOARD. NO ISSUES RELATED TO BURNING SMELL OR DAMAGED COMPONENTS WERE OBSERVED WITHIN THE AUTOMATED IMPELLA CONTROLLER.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT DID NOT OCCUR DURING PATIENT USE. SECTION A WAS LEFT BLANK. 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

    IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE THE AUTOMATED IMPELLA CONTROLLER GENERATED A BOOTUP/SELF-CHECK ALARM AND GAVE OFF A BURNING ODOR. THERE WAS NO PATIENT USE AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2841323 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1378679 00813502011289

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown