BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 20895868 · Received December 10, 2024

    Report

    Report Number
    1220648-2024-24675
    Event Type
    Malfunction
    Date Received
    December 10, 2024
    Date of Event
    September 14, 2021
    Report Date
    December 10, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502010022
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE REPORTED CONTROLLER ALARM HAS BEEN COMPLETED. DATA ANALYSIS: COMPLAINT IS CONSISTENT WITH OCCURRENCE DATE. ON 9/14/21, IMCLOGS SHOW THE FOLLOWING: 14/09/21 08:08:16 IMC-KBD ERROR: 0XA4 0X02 0X00 - KEYBOARD: READ FAILURE. 14/09/21 08:08:57 IMCGUI: EVENT SET: #24 FROM 80 (0) - CONTROLLER ERROR (LOSS OF COMM WITH KEYPAD OR BETWEEN THE KBD AND I2C FOR KBD HW REVISION 1). DEVICE ANALYSIS: CONSOLE FAILURE MODE COULD NOT BE REPRODUCED BY POWER CYCLING CONSOLE. CONCLUSION: FAILURE MODE EXHIBITED IN THE FIELD IS MOST LIKELY DUE TO THE AGE OF THE COMPONENTS IN IC1207. THE ROOT CAUSE OF THE ONE-OFF KBD READ FAILURE AND SUBSEQUENT CONTROLLER ERROR ARE MOST LIKELY DUE TO MISSED COMMUNICATION FROM THE KBD TO 4-IN-1 AND/OR VICE VERSA. HOWEVER, THE EXACT ROOT CAUSE IS UNDETERMINED DUE TO BEING UNABLE TO REPRODUCE THE FAILURE MODE.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT DURING A TRAINING SESSION WHEN, THE AUTOMATED IMPELLER CONTROLLER DISPLAYED AN ALARM FOR "CONTROLLER ERROR SWITCH TO BACK UP CONTROLLER " AFTER IT WAS BOOTED UP. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2521935 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1085509 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown