BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 20626656 · Received November 7, 2024

    Report

    Report Number
    1220648-2024-22292
    Event Type
    Malfunction
    Date Received
    November 7, 2024
    Date of Event
    July 15, 2021
    Report Date
    November 6, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011289
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED, BUT THE INVESTIGATION FOR THE REPORTED CONTROLLER ERROR (YELLOW ALARM) HAS BEEN COMPLETED WITH DATA PROVIDED. CONSOLE LOGS FROM THE REPORTED DAY OF EVENT ARE CONSISTENT WITH COMPLAINT AND SHOW CONTROLLER ERROR ALARM #24 DUE TO LOSS OF COMMUNICATION WITH KBD. THE ISSUE WAS RESOLVED AFTER POWER-CYCLING THE CONSOLE. WHEN CONSOLE WAS RECEIVED AT THE LAB AND INSPECTED, A DAMAGED CONNECTOR ON THE KBD ASSEMBLY WAS DISCOVERED. THE CAUSE OF THE CONTROLLER ERROR ALARM WAS COMMUNICATION GLITCH/LOSS BETWEEN KBD AND 4-IN-1 DUE TO COMPROMISED CONNECTOR ON THE KBD ASSEMBLY. THE CAUSE OF CONNECTOR DAMAGE WAS NOT DETERMINED. 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 THE AUTOMATED IMPELLA CONTROLLER (AIC) PRODUCED AN "AIC ERROR / SWITCH TO BACKUP CONTROLLER" MESSAGE DURING A ROUTINE CHECK. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1395891 AUTOMATED IMPELLA CONTROLLER CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS OZD ABIOMED, INC. IMPELLA CONTROLLER, PACKAGED, EU 1156294 00813502011289

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown