BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 20646747 · Received November 9, 2024

    Report

    Report Number
    1220648-2024-22757
    Event Type
    Malfunction
    Date Received
    November 9, 2024
    Date of Event
    November 30, 2021
    Report Date
    November 8, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502010022
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED AND EVALUATED, AND THE INVESTIGATION FOR THE REPORTED DISPLAY ISSUE HAS BEEN COMPLETED. CONSOLE LOGS DO NOT HAVE ANY ENTRIES ON THE REPORTED DAY OF EVENT, BUT LATER THERE WAS A CONTROLLER ERROR DUE TO KBD COMMUNICATION LOSS, WHICH MIGHT HAVE RESULTED IN KBD BEING UNRESPONSIVE EVEN AFTER A POWER-CYCLE (ALTHOUGH THE ALARM DID NOT RE-OCCUR). VISUAL INSPECTION OF THE CONSOLE PERFORMED IN DANVERS REVEALED SOME IRREGULARITIES, MOST NOTABLY: MISSING TAMPER EVIDENT SEAL FROM THE TOP OF CONSOLE. DEGRADED/DISCOLORED RIBBON CABLE BETWEEN KBD AND 4-IN-1, WHICH WOULD BE RESPONSIBLE FOR GLASS KBD TO BECOME OCCASIONALLY UNRESPONSIVE. THE RIBBON CABLE BETWEEN IMPELLATRONIC AND 4-IN-1 WAS FOUND TO BE SEVERELY KINKED AND LIKELY TO AFFECT IMPELLATRONIC OPERATION IN THE FUTURE. THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

    Description of Event or Problem · 0

    THE USER FACILITY'S BIOMEDICAL ENGINEER REPORTED THE AUTOMATED IMPELLA CONTROLLER (AIC) HAD A FROZEN SCREEN, WHICH WAS NOT RESOLVED BY RESTARTING THE CONSOLE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1875644 AUTOMATED IMPELLA CONTROLLER CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1084840 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown