BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 23031609 · Received September 11, 2025

    Report

    Report Number
    1220648-2025-31366
    Event Type
    Malfunction
    Date Received
    September 11, 2025
    Date of Event
    July 26, 2024
    Report Date
    September 11, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502010022
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF OPTICAL SIGNAL ISSUES IN ACCORDANCE WITH FDA RECOMMENDATION. CONSOLE LOGS FROM THE REPORTED DAY OF EVENT ARE CONSISTENT WITH COMPLAINT AND SHOW ¿PLACEMENT SIGNAL NOT RELIABLE¿ (PSNR) CONDITION ONSET BEFORE AND AFTER PUMP START, AND LATER MULTIPLE ¿INVALID SAMPLE DUE TO SNR BELOW MINIMUM¿ ERRORS. CONSOLE WAS TESTED IN DANVERS AFTER IT ARRIVED FOR INVESTIGATION (B)(4), AND INITIALLY THE ISSUE WAS NOT REPRODUCED. UPON VISUALIZING ANALOG OUTPUT OF THE CCD FROM OPTICAL BENCH, WE OBSERVED INTERMITTENT DISTORTIONS OF THE SIGNAL (ENVELOPE / FRINGE) WITH INCREASING FREQUENCY, THE LONGER THE BENCH WAS OPERATING. WHEN NOT DISTORTED, MEASURED ¿5S¿ PARAMETERS ARE WITHIN SPECIFICATION. BECAUSE OF THE INTERMITTENT NATURE OF THIS FAILURE MODE, CONSOLE IC6002 PASSED FUNCTIONAL TEST ON 2025-07-10 (AFTER PRIOR EVENT ON 2024-04-12 INVESTIGATED IN (B)(4)) WITH ¿5S¿ PARAMETERS WITHIN SPECIFICATION. THE CAUSE OF THE AUTOMATED IMPELLA CONTROLLER (AIC) ISSUE WAS A DEFECTIVE OPTICAL BENCH. REPAIR: REPLACE OPTICAL BENCH ASSEMBLY (0042-3015) AND PERFORM FUNCTIONAL CHECK OF THE CONSOLE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE SUSPECT DEVICE AND HISTORICAL COMPLAINT DATA WAS CONDUCTED. PLEASE REVIEW DHR CHECKLIST FOR INDICATIONS OF: "22-11697-1: BATTERY FAILURE ALARM DUE TO DISENGAGED BATTERY SWITCH 22-10874-1: PURGE DISK NOT DETECTED DUE TO BROKEN FLAG" THIS REVIEW REVEALED THAT THE PRODUCT MET ALL MANUFACTURING RELEASE CRITERIA, AND NO PRODUCT DEFICIENCIES WERE IDENTIFIED AT THE TIME PRODUCT WAS MANUFACTURED AND RELEASED TO THE CUSTOMER. ALL PERTINENT INFORMATION AVAILABLE TO ABIOMED HAS BEEN SUBMITTED AT THIS TIME.

    Description of Event or Problem · 0

    US COMPLAINANT REPORTED THE PATIENT WAS ON IMPELLA CP SUPPORT AND THERE WERE PLACEMENT SIGNAL ISSUES. THE PLACEMENT SIGNAL WAS ABSENT WITH DASH MARKS. THE IMPELLA SUPPORT CONTINUED, AND THE PLACEMENT SIGNAL RETURNED. NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2365374 AUTOMATED IMPELLA CONTROLLER CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS OZD ABIOMED, INC. IMPELLA CONTROLLER, PACKAGED, US 1339213 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Male