BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 20626876 · Received November 7, 2024

    Report

    Report Number
    1220648-2024-22318
    Event Type
    Malfunction
    Date Received
    November 7, 2024
    Date of Event
    May 9, 2021
    Report Date
    November 6, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011289
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE REPORTED CONTROLLER FAILURE ISSUE HAS BEEN COMPLETED. THE PRODUCT WAS RETURNED (NO EXACT RETURN DATE AVAILABLE), AND THE ISSUE WAS CONFIRMED. DATA ANALYSIS: COMPLAINT WAS CONFIRMED VIA THE CONSOLE LOGS. IMC LOGS REVEALED THAT THE CONSOLE TRIGGERED A CONTROLLER FAILURE (LOSS OF COMMUNICATION TO PUD) AND WOULD ALSO NOT PASS SYSTEM SELF-CHECK FEW DAYS LATER. DEVICE ANALYSIS: THE FAILURE WAS REPRODUCED IN FS AACHEN. PER THE RESULTS OF THE CLINICAL REVIEW AND INVESTIGATION, THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE PUD BOARD. THE CAUSE OF THE DEFECTIVE PUD BOARD WAS UNABLE TO BE DETERMINED. THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED FOR AN AUTOMATED IMPELLA CONTROLLER (AIC) THAT THE AIC EXPERIENCED A CONTROLLER FAILURE RED ALARM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1997911 AUTOMATED IMPELLA CONTROLLER CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1090690 00813502011289

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown