BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 20738148 · Received November 20, 2024

    Report

    Report Number
    1220648-2024-23659
    Event Type
    Malfunction
    Date Received
    November 20, 2024
    Date of Event
    October 28, 2024
    Report Date
    December 1, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011814
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    A2 AGE SHOULD HAVE BEEN LEFT BLANK ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-23659 AS NO PATIENT WAS INVOLVED. D2 REVISED COMMON DEVICE NAME AS IT WAS REPORTED INCORRECTLY ON INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-23659. E1 REVISED NAME PREFIX/TITLE AS IT WAS REPORTED INCORRECTLY ON INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-23659. G1 REVISED MDR REPORTING CONTACT EMAIL AS IT WAS REPORTED INCORRECTLY ON INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-23659. G2 FOREIGN SELECTED WAS ADDED AS IT WAS INADVERTENTLY OMITTED FROM INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-23659. H6 CODES 4114 AND 3221 WERE REPORTED INCORRECTLY ON INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-23659.

    Description of Event or Problem · 0

    THE COMPLAINANT HAD AN AUTOMATED IMPELLA CONTROLLER (AIC) AT DISTRIBUTION CENTER AND BEING SHIPPED WHEN THE AIC WAS ASSESSED AND FOUND TO HAVE THE INABILITY TO SHUT DOWN PROPERLY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2013093 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1853697 00813502011814

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown