BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 20616864 · Received November 6, 2024

    Report

    Report Number
    1220648-2024-22151
    Event Type
    Malfunction
    Date Received
    November 6, 2024
    Date of Event
    March 25, 2022
    Report Date
    November 5, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502010022
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE REPORTED KBD/ROTARY KNOB ISSUES ISSUE HAS BEEN COMPLETED. THE PRODUCT WAS RETURNED, AND THE ISSUE WAS CONFIRMED. DATA ANALYSIS: IMC LOGS ON EVENT OCCURRED TIME WERE CONSISTENT WITH THE COMPLAINT. AT THE BEGINNING OF ONE POWER CYCLE, IMC INDICATED THAT KBD FUNCTIONED AS NORMAL. THEN, REPETITIVE ENTRIES OF KBD ERROR OCCURRED, INDICATING KBD WAS NOT RESPONSIVE MOMENTARILY (DUE TO ESD GUARD). HOWEVER, IMC LOGS SHOW THAT KBD WAS BACK TO WORKING CONDITION LATER WITHOUT KBD ERROR. DEVICE ANALYSIS: THE CONSOLE WAS INVESTIGATED AND TESTED ON AN ENGINEERING BENCH. HOWEVER, THE KBD NOT RESPONSIBLE ISSUE WAS NOT REPRODUCED. THE CONSOLE WAS OPENED, VISUAL INSPECTION ON KBD REVEALED A CONTAMINATION ON CAPACITOR C4, BUT IT WAS UNLIKELY THE ROOT CAUSE OF KBD MALFUNCTION. PER THE RESULTS OF THE CLINICAL REVIEW AND INVESTIGATION, THE ROOT CAUSE OF THE ISSUE WAS NOT DETERMINED SINCE THE FAILURE MODE WAS NOT REPRODUCED. THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT THE AUTOMATED IMPELLA CONTROLLER (AIC) WAS BOOTED UP TO THE START SCREEN, HOWEVER THE SOFT KEYS WOULD NOT WORK. THERE WAS NO REPORT OF PATIENT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1405432 AUTOMATED IMPELLA CONTROLLER CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1095654 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown