BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 18651848 · Received February 6, 2024

    Report

    Report Number
    1220648-2024-06600
    Event Type
    Malfunction
    Date Received
    February 6, 2024
    Date of Event
    January 18, 2024
    Report Date
    December 3, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE AUTOMATED IMPELLA CONTROLLER (AIC) CONTROLLER WAS RECEIVED FOR EVALUATION. UPON INVESTIGATION COMPLETION, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 0

    A.2 AGE SHOULD HAVE BEEN LEFT BLANK ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-06600 AS IT IS UNKNOWN. A.3 UNKNOWN SHOULD HAVE BEEN SELECTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-06600 AS IT IS UNKNOWN. D.1 AND D.2 BRAND NAME AND COMMON DEVICE NAME WERE REVISED IN ACCORDANCE WITH UPDATED PROCEDURES SINCE THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-06600 WAS SUBMITTED. D.4 REVISED MODEL NUMBER, CATALOG NUMBER AND SERIAL NUMBER AS THEY WERE REPORTED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-06600. D.9 ADDED DEVICE RETURN DATE AS IT WAS INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER G.1 REVISED REPORTING CONTACT EMAIL IN ACCORDANCE WITH UPDATED PROCEDURES SINCE THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-06600 WAS SUBMITTED. H.3 REVISED AS IT WAS REPORTED INCORRECTLY ON INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-06600. H.6 CODE 2199 AND 3221 WERE REPORTED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-06600. A NEW CODE WAS ADDED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THE AUTOMATED IMPELLA CONTROLLER (AIC) DISPLAYED RED ALARM WITH AIC FAILURE DURING PREP. THE CONSOLE WAS EXCHANGED AND THERE WAS NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2030717 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1140349

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown