BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 19679976 · Received July 5, 2024

    Report

    Report Number
    1220648-2024-12924
    Event Type
    Malfunction
    Date Received
    July 5, 2024
    Date of Event
    May 8, 2024
    Report Date
    July 5, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502010022
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS BEEN COMPLETED. THE AUTOMATED IMPELLA CONTROLLER (AIC) WAS RECEIVED AND TESTED AND AFTER THE CONSOLE REBOOTED, THE LOG INDICATED THAT THE SAME ¿SH.CORE¿ FILE HAD BEEN DELETED. THIS IS AN UNREPORTED FAILURE MODE. UNABLE TO REPRODUCE THE UNEXPECTED REBOOT OR SYSTEM SELF-CHECK FAILED ERROR FORCEFULLY BY PASSING THE ¿SLAY -S SIGABRT SH¿ COMMAND VIA TELNET. THE ROOT CAUSE OF THE INTERMITTENT CONSOLE REBOOT WAS NOT DETERMINED DUE TO THE INABILITY TO REPRODUCE.

    Description of Event or Problem · 0

    US COMPLAINANT REPORTED THE AUTOMATED IMPELLA CONTROLLER (AIC) HAD AN ISSUE WHERE THE OPEN-DOOR BUTTON WAS STICKING. THE PURGE DOOR WOULD NOT CLOSE. THIS ISSUE WAS DISCOVERED IN A DEMONSTRATION IN SERVICE, NOT WITH A PATIENT. IT WAS REPORTED THAT DURING THE INVESTIGATION, THE LOGS WERE REVIEWED AND FOUND THAT A FILE WAS DELETED. THERE WAS A FILE WITH A SYSTEM SELF-CHECK FAILED ISSUE AND AFTER THE CONSOLE REBOOTED, THE SYSTEM SELF-CHECK FAILED FILE PREVIOUS STORED WAS DELETED. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466439 AUTOMATED IMPELLA CONTROLLER CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1146845 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown