BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 17950274 · Received October 17, 2023

    Report

    Report Number
    1220648-2023-04091
    Event Type
    Malfunction
    Date Received
    October 17, 2023
    Date of Event
    September 18, 2023
    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
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA CONSOLE 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

    D.9 DEVICE RETURN DATE WAS ADDED. A.2 AGE SHOULD HAVE BEEN LEFT BLANK IN ACCORDANCE WITH UPDATED PROCEDURES ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-04091 AS IT IS UNKNOWN. A.3 UNKNOWN SHOULD HAVE BEEN SELECTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-04091 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 1220648-2023-04091 WAS SUBMITTED. D.4 MODEL NUMBER WAS REVISED IN ACCORDANCE WITH UPDATED PROCEDURES SINCE THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-04091 WAS SUBMITTED. D.4 REVISED CATALOG NUMBER, LOT NUMBER, UNIQUE IDENTIFIER (UDI) # AND SERIAL NUMBER AS THEY WERE REPORTED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-04091. G.1 REVISED MDR REPORTING CONTACT EMAIL SINCE THE INITIAL SUBMISSION OF MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-04091 IN ACCORDANCE WITH UPDATED PROCEDURES. ADDED REPORTING CONTACT FAX NUMBER IN ACCORDANCE WITH UPDATED PROCEDURES SINCE THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-04091 WAS SUBMITTED. ADDED MANUFACTURER SITE FAX NUMBER AS IT WAS INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-04091. H.4 REVISED AS IT WAS PREVIOUSLY ENTERED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-04091. H.6 CODE 3221 WAS REPORTED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-04091 IN ACCORDANCE WITH UPDATED PROCEDURES.

    Description of Event or Problem · 0

    THE US COMPLAINANT HAD AN AUTOMATED IMPELLA CONTROLLER (AIC) CONTROLLER WITH A PURGE ALARM. THE VAD COORDINATOR NOTED THERE WAS A PROMPT FOR DISCONNECTION OF THE LUER AFTER PURGE IN AIR ALARM. THERE WAS NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65901 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1097391 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown