BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 20638858 · Received November 8, 2024

    Report

    Report Number
    1220648-2024-22533
    Event Type
    Malfunction
    Date Received
    November 8, 2024
    Date of Event
    January 4, 2022
    Report Date
    November 8, 2024
    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
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS BEEN COMPLETED. THE LOGS FROM THE COMPLAINT DATE ARE FILLED WITH COMMUNICATION ERRORS FROM THE PURGE SYSTEM. THERE WAS A CONTROLLER ERROR AND A BATTERY FAILURE OBSERVED IN THE LOGS. THE SYSTEM SELF-CHECK FAILURE WAS REPRODUCED ON AN ENGINEERING BENCH. AS RECEIVED, THE CONSOLE WOULD NOT BOOT UP (FAILED SYSTEM SELF-CHECK). UPON FURTHER ANALYSIS, "FWCHECK" REVEALED THAT THE HARDWARE REVISION AND SOFTWARE VERSION FOR THE PUD MODULE WAS ¿N.A.¿. THE CAUSE OF THE BATTERY FAILURE WAS DUE TO BATTERY DEPLETION. THE CAUSE OF THE CONTROLLER FAILURE WAS DUE TO DEFECTIVE OPTICAL BENCH. THE EXACT ROOT CAUSE OF THE DEFECTIVE OPTICAL BENCH WAS UNABLE TO BE DETERMINED. THE DEFECTIVE PUD WAS TEMPORARILY REPLACED WITH A KNOWN GOOD ONE, WHICH SOLVED THE SYSTEM SELF-CHECK FAILURE. THE SYSCALL ERROR IS DUE TO PUD CORRUPTION. THE FAILURE CAUSE WAS LIKELY LINKED TO THE SOFTWARE INSTALLATION PROCESS AND NOT THE CONSOLE¿S ORIGINAL HARDWARE. THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

    Description of Event or Problem · 0

    THE USER FACILITY¿S BIOMEDICAL ENGINEER REPORTED AN AUTOMATED IMPELLA CONTROLLER FAILED TO BOOT UP. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. ADDITIONAL INFORMATION WAS FOUND DURING INVESTIGATION OF THE DEVICE. THERE WAS A CONTROLLER ERROR AND A BATTERY FAILURE OBSERVED IN THE LOGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1849758 AUTOMATED IMPELLA CONTROLLER CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1207018 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown