BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 18047184 · Received November 1, 2023

    Report

    Report Number
    1220648-2023-04707
    Event Type
    Malfunction
    Date Received
    November 1, 2023
    Date of Event
    June 30, 2021
    Report Date
    November 1, 2023
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502010022
    PMA / PMN Number
    K110845
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONSOLE WAS RETURNED FOR ANALYSIS. ROOT CAUSE IS DUE TO A MALFUNCTIONING PUD BOARD. THE ROOT CAUSE OF THE MALFUNCTIONING PUD BOARD IS UNABLE TO BE DETERMINED. BEFORE RETURNING TO CUSTOMER, FIELD SERVICE REMEDIED THE ISSUE.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A 64-YEAR-OLD MALE UNDERGOING CARDIAC SURGERY WAS IMPLANTED WITH AN IMPELLA 5.5 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. THE US COMPLAINANT HAD AN AUTOMATED IMPELLA CONTROLLER (AIC) FAIL. THE IFU WAS FOLLOWED AND A BACKUP CONTROLLER WAS USED. NO HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2043440 AUTOMATED IMPELLA CONTROLLER AUTOMATED IMPELLA CONTROLLER (AIC) OZD ABIOMED, INC. IMPELLA CONTROLLER, PACKAGED, US 2022058029 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male