BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 22725597 · Received August 6, 2025

    Report

    Report Number
    1220648-2025-45721
    Event Type
    Malfunction
    Date Received
    August 6, 2025
    Date of Event
    July 25, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011401
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE AUTOMATED IMPELLA CONTROLLER DEVICE WAS NOT RECEIVED FROM THE CUSTOMER AT THE TIME OF THIS MDR WRITING; THEREFORE, EVALUATION/ANALYSIS OF THE AIC WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE AUTOMATED IMPELLA CONTROLLER DATA LOGS AND CONSOLE WERE RETURNED FOR ANALYSIS AND EVALUATION. DATA ANALYSIS DEMONSTRATED THERE WAS A CONTROLLER FAILURE ALARM. THE CONSOLE WAS POWERED OFF. THREE DAYS LATER THE CONSOLE WAS REBOOTED WITH THE CONTROLLER FAILURE ALARM PERSISTING. ON 25TH JULY 2025, THOUGH THE ENTERPRISE PERFORMANCE MANAGEMENT (EPM) HARDWARE REVISION WAS CORRECT AS A KNOWN GOOD EPM HARDWARE REVISION, THE CONSOLE STILL RECEIVED THE CONTROLLER FAILURE (EPM1 SW-SOFTWARE-CORRUPTION) - ALARM UPON BOOTING. THE CONSOLE WAS POWERED OFF AND REBOOTED AGAIN ON (B)(6) 2025. HOWEVER, THE EVENT PERSISTED. THERE WERE NO BATTERY RELATED ISSUES OR ALARMS WERE SEEN IN THE EVENT LOGS. IT WAS NOTED; CONTROLLER FAILURE ALARM COULD HAVE OCCURRED DUE TO ENTERPRISE PERFORMANCE MANAGEMENT SOFTWARE CORRUPTION OR THE INCOMPATIBLE HARDWARE REVISION. DEVICE ANALYSIS DEMONSTRATED THE CONSOLE WAS RETURNED TO FIELD SERVICE FOR FURTHER INVESTIGATION. THE REPORTED FAILURE MODE WAS ABLE TO BE REPRODUCED. UPON BOOTING, THE CONSOLE RECEIVED THE CONTROLLER FAILURE ALARM. A FIRMWARE CHECK CONDUCTED VIA TELNET CONFIRMED THAT THE ISSUE WAS CAUSED BY A CORRUPTED FIRMWARE ON THE IMPELLATRONIC PRINTED CIRCUIT ASSEMBLY (PCA) BOARD. THIS WAS DETERMINED BY COMPARING THE EXTRACTED FIRMWARE WITH A KNOWN GOOD VERSION. THE IMPELLATRONIC PCA WAS THEN REPLACED WITH A KNOWN GOOD UNIT. FOLLOWING THE REPLACEMENT, THE CONTROLLER FAILURE ALARM WAS NO LONGER TRIGGERED. ADDITIONALLY, THE CONSOLE WAS OPERATED USING A KNOWN GOOD PUMP AND PURGE CASSETTE, AS WELL AS BATTERIES WERE INSPECTED, AND NO ISSUES WERE OBSERVED DURING TESTING. IN CONCLUSION, THE ROOT CAUSE FOR THE CONTROLLER FAILURE (EPM 1 SW CORRUPTION #1029) WAS DUE TO A IMPELLATRONIC PCA FIRMWARE CORRUPTION. HOWEVER, THE CAUSE OF THE FIRMWARE CORRUPTION WAS NOT DETERMINED. H6: INVESTIGATION: TYPE, FINDINGS AND CONCLUSION CODES AND ADDITIONALLY COMPONENT CODING WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED DEVICE/EVENT LOG ANALYSIS AND INVESTIGATION.

    Additional Manufacturer Narrative · 0

    ACCORDINGLY. FURTHERMORE, ADDITIONAL INFORMATION NOTED THE IMPELLA DEVICE WAS RETURNED, AND AN EVALUATION/ANALYSIS IS UNDERWAY. UPON COMPLETION OF THE ANALYSIS, A SUPPLEMENTAL REPORT WILL BE FILED. CORRESPONDINGLY, SECTIONS D9: DEVICE RECEIVED BY MANUFACTURER WITH RECEIPT DATE AND H6: INVESTIGATION TYPE, FINDINGS AND CONCLUSION CODES WERE UPDATED ACCORDINGLY.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THE AUTOMATED IMPELLA CONTROLLER (AIC) SET OFF A CONTROLLER FAILURE ALARM WHEN TURNED ON DURING PREP FOR SUPPORT OF A PATIENT UNDERGOING HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION. CONSEQUENTLY, ANOTHER AIC WAS USED FOR THE CASE, AND THERE WAS NO HARM TO PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528094 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1683914 00813502011401

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male