BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 20617099 · Received November 6, 2024

    Report

    Report Number
    1220648-2024-22159
    Event Type
    Malfunction
    Date Received
    November 6, 2024
    Date of Event
    September 1, 2021
    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
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: NAME OF THE INITIAL REPORTER IS UNKNOWN. THE INVESTIGATION INTO THE KEYBOARD ROTARY KNOB (KBD) ISSUE HAS BEEN COMPLETED. THE IMPELLA AUTOMATED CONTROLLER (AIC) WAS RETURNED FOR INVESTIGATION. THE DATA ANALYSIS OF THE LOGS FROM THE REPORTED DAY OF EVENT ARE CONSISTENT WITH COMPLAINT AND SHOW MULTIPLE "HIGH GUARD LEVEL" ERRORS, INDICATING POSSIBLE ELECTROSTATIC DISCHARGE (ESD) EVENTS, WHICH ARE KNOWN TO BE CAUSING KEYBOARDS TO BE TEMPORARILY UNRESPONSIVE. AFTER 4 MINUTES OF THE KBD BEING UNRESPONSIVE (DURING WHICH ALL OTHER SYSTEMS AND COMPONENTS WERE OPERATING WITHIN SPECIFICATION) THE CONSOLE WAS SHUT DOWN. DURING THE NEXT 90 DAYS, WHEN CONSOLE WAS BEING USED IN THE FIELD, AND BEFORE IT WAS SHIPPED TO THE MANUFACTURER FOR TROUBLESHOOTING, THERE WERE NO ESD EVENTS SHOWN IN THE LOGS AND NO EVIDENCE (OR REPORTS) OF NON-RESPONSIVE KBD. THE ISSUE WAS NOT REPRODUCED, AND THE CONSOLE WAS FOUND TO BE WITHIN SPECIFICATION AND PASSING ALL TESTING. IT IS MOST LIKELY THAT SOME UNDETERMINED ESD EVENT OCCURRED, HOWEVER THE AIC DID NOT RECEIVE ANY PERMANENT DAMAGE. THE CAUSE OF THE KBD BEING UNRESPONSIVE WAS UNABLE TO BE DETERMINED BECAUSE THE ISSUE COULD NOT BE REPRODUCED. THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

    Description of Event or Problem · 0

    THE NURSE REPORTED THAT THE AUTOMATED IMPELLA CONTROLLER (AIC) SOFT MENU BUTTONS WOULD NOT RESPOND TO TOUCHES FOR RUNNING THE DE-AIR PROCESS. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1396194 AUTOMATED IMPELLA CONTROLLER CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 2022079876 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male