BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 20637344 · Received November 8, 2024

    Report

    Report Number
    1220648-2024-22507
    Event Type
    Malfunction
    Date Received
    November 8, 2024
    Date of Event
    August 23, 2022
    Report Date
    November 7, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502010022
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: NAME OF THE INITIAL REPORTER IS UNKNOWN. THE INVESTIGATION INTO THE CONTROLLER ERROR HAS BEEN COMPLETED. THE IMPELLA AUTOMATED CONTROLLER WAS RETURNED FOR INVESTIGATION. THE DATA LOG REPORTS ANALYSIS NOTED THE YELLOW CONTROLLER ALARM CORRESPONDING TO #24 (LOSS OF COMMUNICATION TO THE KEYPAD FOR UP-TO 5 SECS (INCLUDES COMMUNICATION LOSS BETWEEN THE EMBEDDED PASSIVE COMPONENTS (EPC) AND KEYBOARD (KBD) SOFTWARE FOR ALL KBD HARDWARE (HW) REVISIONS OR BETWEEN THE KBD AND I2C FOR KBD HW REVISION 1 AS DEFINED IN 0042-9650)) IS PRESENT IN THE LOGS CORRESPONDING TO THE COMPLAINT. THE RETURNED CONSOLE WAS TESTED, AND THE FAILURE REPRODUCED ON THE LAB BENCH DURING TESTING. THE RIBBON CABLE BETWEEN THE 4 IN1 AND KBD WAS REPLACED WITH A KNOWN GOOD CABLE, BUT THE FAILURE WAS STILL REPRODUCED. IN THE NEXT STEP, THE I2C COMMUNICATION BETWEEN THE KBD AND 4IN1 WAS MONITORED USING AN OSCILLOSCOPE. THE OSCILLOSCOPE WAS CONFIGURED TO MONITOR I2C COMMUNICATION AND TRIGGER WAS SET TO I2C START, SINGLE EVENT CAPTURE. WHILE MONITORING THE I2C PROTOCOL COMMUNICATION, IT WAS FOUND THAT THE KBD INITIALIZATION SEQUENCE CAPTURED ON THE I2C LINE WAS AS EXPECTED (AS PER THE KBD IC SPECIFICATIONS). AS FURTHER TESTING THE 4IN1 WAS REPLACED WITH A KNOWN GOOD 4 IN1, THIS RESOLVED THE ISSUE, AND THE FAILURE WAS NOT REPRODUCED IN THE NEXT 70 POWER CYCLES. THE ROOT CAUSE OF KEYBOARD FREEZE WAS THE MALFUNCTIONING OF MSC1210 PRESENT ON 4-IN-1. THE CAUSE OF THE AIC ISSUE WAS A DEFECTIVE 4IN1 BOARD 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) EXPERIENCED A CONTROLLER ERROR ALARM IMMEDIATELY AFTER BOOTUP. IT WAS REPORTED THAT THE AIC WAS RESTARTED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS AIC. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1849661 AUTOMATED IMPELLA CONTROLLER CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1194348 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown