BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 18078319 · Received November 6, 2023

    Report

    Report Number
    1220648-2023-04817
    Event Type
    Malfunction
    Date Received
    November 6, 2023
    Date of Event
    October 26, 2023
    Report Date
    October 24, 2025
    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 IMPELLA DEVICE WAS RETURNED AND AN EVALUATION IS UNDERWAY. UPON COMPLETION OF OUR ANALYSIS, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    A.1 REVISED AS NONE WAS INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-04817. A.2 AGE SHOULD HAVE BEEN LEFT BLANK ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-04817 AS IT IS UNKNOWN. E.2 REVISED AS IT WAS INCORRECTLY ENTERED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-04817. F.6 AND F.8 DATES WERE REPORTED ON MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-04817 AND SHOULD NOT HAVE BEEN. G.1 REVISED REPORTING CONTACT EMAIL IN ACCORDANCE WITH UPDATED PROCEDURES SINCE THE INITIAL MANUFACTURER DEVICE REPORT 1220648-2024-10844 WAS SUBMITTED. ADDED REPORTING CONTACT FAX NUMBER AS IT WAS INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT 1220648-2024-10844. H.6 CODE 2199 WAS ENTERED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT 1220648-2024-10844.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING A CASE PREPARATION, THE AUTOMATED IMPELLA CONTROLLER, (AIC) PORT WAS DAMAGED. A REPLACEMENT LOANER WAS SENT TO THE FACILITY. NO PATIENT IS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119821 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1273696 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown