BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 20096201 · Received August 29, 2024

    Report

    Report Number
    1220648-2024-17199
    Event Type
    Malfunction
    Date Received
    August 29, 2024
    Date of Event
    August 5, 2024
    Report Date
    February 11, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON COMPLETION OF OUR ANALYSIS, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE CONSOLE (AIC) CONTROLLER FAILURE-RED ALARM HAS BEEN COMPLETED. THE CONSOLE IMC LOGS CONFIRM THAT CONTROLLER ERROR (LOSS OF COMM WITH KEYPAD OR BETWEEN THE KBD AND I2C FOR KBD HW REVISION 1) - ALARM WAS ISSUED AS WELL AS NUMEROUS KEYBOARD COMMUNICATION AND HIGH GUARD LEVEL ERRORS. THE CONSOLE WAS RETURNED FOR EVALUATION. THE CONSOLES INTERNAL CIRCUITRY WAS INSPECTED IN THE LAB. NO CONTROLLER FAILURE ALARM WAS REPRODUCED UPON INITIAL REBOOT OF THE CONSOLE. HOWEVER, A PERSISTENT CONTROLLER ERROR WAS OBSERVED WHEN THE EPC -KBD RIBBON CABLE WAS DETACHED AND RE-ATTACHED. REBOOTING THE CONSOLE RESOLVED THE ALARM. THE PERSISTENCE OF THE ALARM WAS OBSERVED REGARDLESS OF WHAT SIDE OF THE RIBBON CABLE WAS DETACHED AND REATTACHED. REPLACING WITH ANOTHER RIBBON CABLE DIDN'T RESOLVE THE ISSUE. REPLACING BOTH EPC AND KBD RESOLVED THE ISSUE. THE ROOT CAUSE OF THE KBD COMMUNICATION ERROR ALARM WAS MOST LIKELY A DEFECTIVE KEYBOARD AND EPC. CORRECTIONS TO THE INITIAL MFR REPORT: D2 UPDATED COMMON DEVICE NAME G1 MDR REPORTING CONTACT EMAIL H6 IMPACT CODE 4629 ADDED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT THE AUTOMATED IMPELLA CONTROLLER (AIC) HAD A CONTROLLER FAILURE ALARM. THE AIC WAS EXCHANGED AND THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1766546 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1371823

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown