BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 18564977 · Received January 23, 2024

    Report

    Report Number
    1220648-2024-06227
    Event Type
    Malfunction
    Date Received
    January 23, 2024
    Date of Event
    January 12, 2024
    Report Date
    November 21, 2025
    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
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER AND THEREFORE, AN EVALUATION OF THE DEVICE WAS NOT POSSIBLE. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE CONSOLE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MANUFACTURER DEVICE REPORT WILL BE FILED. A.1 ADDED AS INFORMATION WAS INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-06227. A.2 AGE SHOULD HAVE BEEN LEFT BLANK ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-06227 AS NO PATIENT WAS INVOLVED. A.3 ADDED AS INFORMATION WAS INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-06227. D.2 COMMON DEVICE NAME WAS REVISED IN ACCORDANCE WITH UPDATED PROCEDURES SINCE THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-06227 WAS SUBMITTED. D.4 MODEL NUMBER WAS REVISED IN ACCORDANCE WITH UPDATED PROCEDURES SINCE THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-06227 WAS SUBMITTED. CATALOG NUMBER WAS REVISED SINCE THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-06227 WAS SUBMITTED. D.9 DEVICE RETURN DATE WAS ADDED AS IT WAS INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-06227. E.1 REVISED NAME PREFIX/TITLE, FIRST AND LAST NAME AS THEY WERE REPORTED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-06227. F.6 AND F.8 DATES WERE REPORTED ON MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-06227 AND SHOULD NOT HAVE BEEN. G.1 REVISED MDR REPORTING CONTACT EMAIL IN ACCORDANCE WITH UPDATED PROCEDURES SINCE THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-06227 WAS SUBMITTED. ADDED FAX NUMBER AS IT WAS INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-06227. H.3 UPDATED TO DEVICE EVALUATION ANTICIPATED AS IT WAS REPORTED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-06227. H.6 CODE 2199, 4144 AND 3221 WERE REPORTED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-06227. H.10 ADDITIONAL MANUFACTURER NARRATIVE WAS REPORTED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-06227 AS THE CONSOLE WAS RETURNED.

    Description of Event or Problem · 0

    NO PATIENT INVOLVEMENT: THE COMPLAINANT REPORTED A BATTERY FAILURE ON THE AIC (AUTOMATED IMPELLA CONTROLLER). THE AIC WAS REMOVED FROM SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825173 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1590813 00813502011401

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown