BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 20646569 · Received November 8, 2024

    Report

    Report Number
    1220648-2024-22716
    Event Type
    Malfunction
    Date Received
    November 8, 2024
    Date of Event
    August 4, 2022
    Report Date
    November 8, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011401
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE REPORTED BLANK SCREEN ISSUE HAS BEEN COMPLETED. THE PRODUCT WAS RETURNED, AND THE ISSUE WAS CONFIRMED. DATA ANALYSIS: AIC LOGS REVEALED PURGE UNIT DRIVER (PUD) COMMUNICATION ISSUES. DEVICE ANALYSIS: BOOT UP ISSUES WERE REPRODUCED. CONSOLE WOULD NOT PASS SYSTEM SELF-CHECK. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE PUD. THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED FOR AN AUTOMATED IMPELLA CONTROLLER (AIC) IS NOT WORKING AND WILL NOT TURN ON. THIS ISSUE OCCURRED DURING TRAINING, NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2109959 AUTOMATED IMPELLA CONTROLLER CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1635221 00813502011401

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown