BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 19558234 · Received June 18, 2024

    Report

    Report Number
    1220648-2024-12500
    Event Type
    Malfunction
    Date Received
    June 18, 2024
    Date of Event
    June 3, 2024
    Report Date
    January 30, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011289
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CATALOG NUMBER, SERIAL NUMBER, LOT NUMBER AND UNIQUE IDENTIFIER (UDI) # ARE UNKNOWN. DEVICE MANUFACTURE DATE IS UNKNOWN. THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER AND THEREFORE, AN EVALUATION OF THE DEVICE WAS NOT POSSIBLE. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE CONSOLE (AIC) POWER ISSUES HAS BEEN COMPLETED. CONSOLE IMC LOGS CONFIRM THAT THE CONTROLLER FAILURE (PUD COMM LOSS) - ALARM WAS ISSUED. THE AIC WAS RETURNED FOR EVALUATION. THE FAILURE WAS REPRODUCED IN THE LAB. A TEST PC WAS USED TO PERFORM A FIRM WARE CHECK ON THE CONSOLE REVEALING THE PUD NOT BEING RECOGNIZED. THE FAILURE WAS RESOLVED WHEN A KNOWN GOOD PUD WAS SWAPPED INTO THE CONSOLE. THE ROOT CAUSE FOR THE SYSTEM SELF CHECK FAILURE WAS A DEFECTIVE PUD. ADDED D9 DEVICE RETURN DATE CORRECTIONS TO THE INITIAL MFR REPORT: D4-MODEL, CATALOG, SERIAL, AND UDI NUMBERS HAVE BEEN ADDED. F6/F8 SHOULD HAVE BEEN LEFT BLANK. G1 MDR REPORTING CONTACT EMAIL. H4-ADDED DEVICE MFR DATE.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED AN UNSPECIFIED PATIENT UNDERGOING CARDIAC SURGERY WAS IMPLANTED WITH AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT ON ARRIVAL AT THE HOSPITAL TO TRANSFER LOAN MONITORS BACK INTO THE TRANSFER CASE, THE REPRESENTATIVE SWITCHED ON THE HOSPITAL¿S RETURNED AUTOMATED IMPELLA CONTROLLERS (AIC) AS ONE OF THE CONSOLES HAD AN ISSUE SAYING SYSTEM SELF-CHECK FAILED. THE AIC WAS SWITCHING ON AND OFF. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2338664 AUTOMATED IMPELLA CONTROLLER CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 00813502011289

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown