BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 20595552 · Received November 3, 2024

    Report

    Report Number
    1220648-2024-21814
    Event Type
    Malfunction
    Date Received
    November 3, 2024
    Date of Event
    September 26, 2022
    Report Date
    November 3, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502010022
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE REPORTED ISSUE HAS BEEN COMPLETED. THE IMPELLA DEVICE WAS RECEIVED FROM THE CUSTOMER AND AN EVALUATION OF THE DEVICE WAS COMPLETED. THE CAUSE OF THE AIC-PUMP ISSUE WAS AN EEPROM DATA TRANSMISSION CORRUPTION. THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT A PATIENT THAT NEEDED AUTOMATED IMPELLA CONTROLLER (AIC) TO AIC TRANSFER. WHEN TRANSFERRED TO NYU CONSOLE, PLACEMENT SIGNAL NOT RELIABLE ALARM APPEARED, NO PLACEMENT SIGNAL VISIBLE AND IMPELLA DEFECTIVE ALARM. MOTOR CURRENT WAS WITHIN NORMAL LIMIT, PATIENT NOTED HEMODYNAMICALLY STABLE. PUMP WAS UNPLUGGED AND PATIENT PLACED BACK INTO COOPER AIC. PLACEMENT SIGNAL NOT RELIABLE ALARM APPEARED, BUT MOTOR CURRENT NORMAL WITH THE PATIENT BEING PROPERLY SUPPORTED BY 5.5. PATIENT LEFT ON COOPER AIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2166816 AUTOMATED IMPELLA CONTROLLER CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS OZD ABIOMED, INC. IMPELLA CONTROLLER 1327996 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male