BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 20050560 · Received August 23, 2024

    Report

    Report Number
    1220648-2024-16174
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    July 29, 2024
    Report Date
    December 3, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502010022
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE HAS NOT BEEN RECEIVED FROM THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE HAS NOT BEEN POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, 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.2 AGE SHOULD HAVE BEEN LEFT BLANK ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-16174 AS IT IS UNKNOWN. A.3 UNKNOWN SHOULD HAVE BEEN SELECTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-16174 AS IT IS UNKNOWN. D.2 REVISED COMMON DEVICE NAME IN ACCORDANCE WITH UPDATED PROCEDURES SINCE THE INITIAL MANUFACTURER DEVICE REPORT 1220648-2024-16174 WAS SUBMITTED. D.4 REVISED UNIQUE IDENTIFIER (UDI) # AS IT WAS REPORTED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-16174. E.1 ADDED NAME PREFIX/TITLE AND FAX NUMBER AS THEY WERE INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-16174. REVISED FACILITY NAME AS IT WAS REPORTED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-16174. E.2 REVISED AS IT WAS REPORTED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-16174. G.1 REVISED MDR REPORTING CONTACT EMAIL IN ACCORDANCE WITH UPDATED PROCEDURES SINCE THE INITIAL MANUFACTURER DEVICE REPORT 1220648-2024-16174 WAS SUBMITTED.

    Description of Event or Problem · 0

    US COMPLAINANT REPORTED THAT THE AUTOMATED IMPELLA CONTROLLER (AIC) PRESENTED A CONTROLLER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1313458 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1095488 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown