BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 19058735 · Received April 8, 2024

    Report

    Report Number
    1220648-2024-09570
    Event Type
    Malfunction
    Date Received
    April 8, 2024
    Date of Event
    April 4, 2024
    Report Date
    October 10, 2024
    Manufacturer
    ABIOMED, INC
    Product Code
    OZD
    UDI-DI
    00813502011814
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE REPORTED CONSOLE (AIC) BATTERY CHARGING ISSUES HAS BEEN COMPLETED. DATA LOGS CONFIRMED THE REPORTED COMPLAINT OF AN UNEXPECTED SHUTDOWN. HOWEVER, THERE WAS NO EVIDENCE OF A PRECEDING CONTROLLER ALARM. IMMEDIATELY PRECEDING THE UNEXPECTED SHUTDOWN, THE FOLLOWING EVENT OCCURRED: ¿SYSTEMIDLE: PROCESS IO-GRAPHICS 339995 DIED ABNORMALLY¿. PREVIOUS INVESTIGATIONS OF RELATED UNEXPECTED SHUTDOWN ISSUES INDICATE THAT A CRASH OF THE IO-GRAPHICS PROCESS WITHIN THE CONSOLE'S UNDERLYING QNX OPERATING SYSTEM CAUSED THE UNEXPECTED SHUTDOWN OF THE CONSOLE. THE DEVICE WAS RETURNED FOR EVALUATION. NO APPARENT ISSUES WERE IDENTIFIED. THE REPORTED COMPLAINT COULD NOT BE REPRODUCED. CORRECTIONS TO THE INITIAL MFR REPORT:F6/F8 SHOULD HAVE BEEN LEFT BLANK.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    A JAPAN USER FACILITY REPORTED A 58-YEAR-OLD MALE PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS THAT THAT THE AUTOMATED IMPELLA CONTROLLER (AIC) HAD A CONTROLLER ERROR ALARM, AND THE SCREEN WENT DARK. A REBOOT WAS REQUIRED. THE AIC WAS REPLACED FOR PATIENT¿S SAFETY. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96546 AUTOMATED IMPELLA CONTROLLER CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS OZD ABIOMED, INC AUTOMATED IMPELLA CONTROLLER 1673731 00813502011814

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male