BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 20647617 · Received November 9, 2024

    Report

    Report Number
    1220648-2024-22775
    Event Type
    Malfunction
    Date Received
    November 9, 2024
    Date of Event
    May 12, 2021
    Report Date
    November 9, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502010022
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED AND EVALUATED, AND THE INVESTIGATION FOR THE REPORTED CONTROLLER ERROR (YELLOW ALARM) HAS BEEN COMPLETED. ON THE COMPLAINT DATE, THE IMC LOGS REVEALED THAT THERE WAS A KBD READ FAILURE WHICH RESULTED IN A CONTROLLER ERROR (EVENT SET #24 - LOSS OF COMM WITH KEYPAD). THE FAILURE MODE WAS NOT REPRODUCED AFTER POWER CYCLING THE CONSOLE 150 TIMES. THERE WERE ALSO NO UNDERLYING KBD ERRORS FOUND IN THE LOG ANALYSIS AFTERWARDS. THERE WAS ALSO NO DISCOLORATION ON THE RIBBON CABLE BETWEEN THE 4-IN-1 AND KBD. THE CAUSE OF THE CONTROLLER ERROR (LOSS OF COMMUNICATION TO KBD) WAS UNABLE TO BE DETERMINED BECAUSE THE ISSUE WAS UNABLE TO BE REPRODUCED. 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) EXPERIENCED A CONTROLLER ERROR YELLOW ALARM THAT WAS RESOLVED BY REPLACING THE CONSOLE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1903568 AUTOMATED IMPELLA CONTROLLER CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS OZD ABIOMED, INC. IMPELLA CONTROLLER, PACKAGED, US 1107436 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown