BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 18021523 · Received October 27, 2023

    Report

    Report Number
    1220648-2023-04612
    Event Type
    Malfunction
    Date Received
    October 27, 2023
    Date of Event
    September 27, 2023
    Report Date
    November 14, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502010022
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A.1 ADDED INFORMATION AS IT WAS INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-04612. A.2 AGE SHOULD HAVE BEEN LEFT BLANK IN ACCORDANCE WITH UPDATED PROCEDURES ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-04612 AS NO PATIENT WAS INVOLVED. D.2 COMMON DEVICE NAME WAS REVISED IN ACCORDANCE WITH UPDATED PROCEDURES SINCE THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-04612 WAS SUBMITTED. D.4 MODEL NUMBER WAS REVISED IN ACCORDANCE WITH UPDATED PROCEDURES SINCE THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-04612 WAS SUBMITTED. E.2 REVISED SELECTION AS IT WAS REPORTED INCORRECTLY FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-04612. F.6 AND F.8 DATES WERE REPORTED ON MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-04612 AND SHOULD NOT HAVE BEEN. G.1 REVISED MDR REPORTING CONTACT EMAIL SINCE THE INITIAL SUBMISSION OF MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-04612 IN ACCORDANCE WITH UPDATED PROCEDURES. H.6 CODE 3221 WAS REPORTED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-04612 IN ACCORDANCE WITH UPDATED PROCEDURES.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE HAS BEEN RECEIVED FROM THE CUSTOMER HOWEVER, THE EVALUATION OF THE DEVICE IS NOT COMPLETE. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 0

    THE USER FACILITY'S BIOMEDICAL ENGINEER REPORTED THAT THE AUTOMATED IMPELLA CONTROLLER (AIC) WAS POWERED ON TO CHECK FOR SOFTWARE STATUS AND A "CONTROLLER ERROR-SWITCH TO BACK UP" ALARM POPULATED. THE CONSOLE WAS TAKEN OUT OF THE LAB AND WILL BE RETURNED FOR INVESTIGATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1690860 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1162029 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown