BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 18553184 · Received January 22, 2024

    Report

    Report Number
    1220648-2024-06184
    Event Type
    Malfunction
    Date Received
    January 22, 2024
    Date of Event
    January 12, 2024
    Report Date
    December 3, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502010961
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    003

    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 INFORMATION AS IT WAS INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-06184. A.2 AGE SHOULD HAVE BEEN LEFT BLANK ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-06184 AS NO PATIENT WAS INVOLVED. A.3 ADDED INFORMATION AS IT WAS INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-06184. D.2 COMMON DEVICE NAME WAS REVISED IN ACCORDANCE WITH UPDATED PROCEDURES SINCE THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-04722 WAS SUBMITTED. D.9 DEVICE RETURN DATE WAS ADDED AS IT WAS INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-06184. E.1 REVISED NAME PREFIX/TITLE AS IT WAS REPORTED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-06184. E.2 AND E.3 REVISED AS THEY WERE REPORTED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-06184. F.6 AND F.8 DATES WERE REPORTED ON MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-06184 AND SHOULD NOT HAVE BEEN. G.1 REVISED MDR REPORTING CONTACT ADDRESS AND MANUFACTURING SITE NAME AND ADDRESS AS THEY WERE REPORTED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-06184. H.3 UPDATED TO REFLECT DEVICE EVALUATION ANTICIPATED AS IT WAS REPORTED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-06184. H.6 CODE 4144 AND 3221 WERE REPORTED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-06184. H.10 ADDITONAL MANUFACTURER NARRATIVE WAS REPORTED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-06184 AS THE DEVICE WAS RETURNED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING ROUTINE MAINTENANCE, THE POWER FAIL ALARM OF THE AUTOMATED IMPELLA CONTROLLER (AIC) WAS NOT WORKING. THERE WAS NO PATIENT HARM OR INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404749 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1629362 00813502010961

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown