BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 20766995 · Received November 23, 2024

    Report

    Report Number
    1220648-2024-24101
    Event Type
    Malfunction
    Date Received
    November 23, 2024
    Date of Event
    November 5, 2024
    Report Date
    August 14, 2025
    Manufacturer
    ABIOMED. INC.
    Product Code
    OZD
    UDI-DI
    00813502010022
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1, E2, E3: THE NAME AND OCCUPATION OF THE INITIAL REPORTER IS UNKNOWN. THE DEVICE WAS RETURNED, AND THE EVALUATION IS IN PROCESS. UPON COMPLETION OF THE INVESTIGATION 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 1220648-2024-24101 AS IT IS UNKNOWN. A.3 UNKNOWN SHOULD HAVE BEEN SELECTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-24101 AS IT IS UNKNOWN. D.2 REVISED COMMON DEVICE NAME AS IT WAS ENTERED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-24101. D.4 REVISED SERIAL NUMBER AS IT WAS ENTERED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-24101. E.1 NAME PREFIX/TITLE, FIRST AND LAST NAME ARE KNOWN AND WERE ADDED TO THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-24101. PHONE NUMBER WAS ENTERED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-24101. E.2 AND E.3 ADDED INFORMATION AS IT WAS INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-24101. H.1 REVISED AS IT WAS ENTERED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-24101. H.6 CODE 10 WAS REPORTED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-24101.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT THE AUTOMATED IMPELLA CONTROLLER (AIC) EXHIBITED A CONTROLLER ERROR. THIS OCCURRED DURING PREPARATION FOR A CASE WITH NO REPORTED HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2606625 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED. INC. AUTOMATED IMPELLA CONTROLLER 1150343 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown