BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 21312671 · Received February 5, 2025

    Report

    Report Number
    1220648-2025-26001
    Event Type
    Malfunction
    Date Received
    February 5, 2025
    Date of Event
    January 20, 2025
    Report Date
    March 12, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502010961
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF AUTOMATED IMPELLA CONTROLLER (AIC) - POWER ON ISSUES/BLANK SCREEN HAS BEEN COMPLETED. NO CONSOLE LOGS WERE OBSERVED FROM THE REPORTED COMPLAINT DATE. THIS WAS TO BE EXPECTED GIVEN THE USER WAS NOT ABLE TO STARTUP THE CONSOLE. HOWEVER, THERE WERE LOGS OBSERVED PRIOR TO THE COMPLAINT DATE THAT WERE INDICATIVE OF A MALFUNCTIONING. CONSOLE WAS TESTED AFTER ARRIVING IN FIELD SERVICE. THE REPORTED STARTUP ISSUE COULD NOT BE REPRODUCED. THE CONSOLE WAS ABLE TO START UP NORMALLY. IN EFFORT TO INVESTIGATE THE CAUSE OF THE KBD ERRORS, THE CABLES FROM THE 4-IN-1 TO THE KBD AND POWER BATTERY MANAGER (PBM) TO 4-IN-1 WERE INSPECTED, BUT NO ISSUES WERE FOUND. THE LOGS THAT WERE INDICATIVE OF A MALFUNCTIONING 4-IN-1 SUBSIDED WHEN TESTING THIS CONSOLE WITH A KNOWN GOOD 4-IN-1. CONCLUSION: THE IMC-KBD ERROR¿S OBSERVED IN THE LOGS WERE CAUSED BY A MALFUNCTIONING 4-IN-1. THE CAUSE OF THE START UP ISSUES WERE NOT DETERMINED DUE TO THE INABILITY TO REPRODUCE. D6A/D6B SHOULD HAVE BEEN LEFT BLANK ON MANUFACTURER DEVICE REPORT 1220648-2025-26001, DUE TO THE THIS COMPLAINT IS FOR A CONSOLE WHICH IS NOT AN IMPLANTABLE DEVICE. H6 CODE 925 WAS REPORTED INCORRECTLY ON MANUFACTURER DEVICE REPORT 220648-2025-26001. NEW CODE WAS ADDED TO COMPONENT CODE

    Additional Manufacturer Narrative · 0

    THE CONSOLE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MANUFACTURER DEVICE REPORT WILL BE FILED.

    Description of Event or Problem · 0

    A COMPLAINANT REPORTED THE AUTOMATED IMPELLA CONTROLLER (AIC) COULD NOT BE STARTED. THE AIC WAS CONNECTED TO THE POWER SUPPLY THE WHOLE TIME, EVEN THE SMALL GREEN LIGHT WAS ON. HOWEVER, THERE WAS NO REACTION ON THE DISPLAY. THE AIC WAS REPLACED AND THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1159124 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1557936 00813502010961

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male