BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 18260453 · Received December 4, 2023

    Report

    Report Number
    1220648-2023-05229
    Event Type
    Malfunction
    Date Received
    December 4, 2023
    Date of Event
    November 5, 2023
    Report Date
    November 17, 2025
    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 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

    A.2 REVISED AGE AS IT WAS REPORTED INCORRECTLY ON INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-05229. A.3 AND A.5 ADDED GENDER AND ETHNICITY AS THEY WERE INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-05229. B.3 REVISED DATE OF EVENT AS IT WAS REPORTED INCORRECTLY ON INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-05229. D.1 REVISED BRAND NAME AS IT WAS REPORTED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-05229. D.4 REVISED MODEL NUMBER AND CATALOG NUMBER FROM THE INITIAL SUBMISSION OF MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-05229 IN ACCORDANCE WITH UPDATED PROCEDURES. D.9 DEVICE RETURNED TO MANUFACTURER DATE WAS ADDED AS IT WAS INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-05229. E.1 ADDED ADRRESS LINE 2 AS IT WAS INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-05229. F.6 AND F.8 DATES WERE REPORTED ON MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-05229 AND SHOULD NOT HAVE BEEN. G.1 REPORTING CONTACT EMAIL WAS REVISED SINCE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-05229 WAS SUBMITTED IN ACCORDANCE WITH UPDATED PROCEDURES. REPORTING CONTACT FAX NUMBER WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-05229 AND WAS ADDED. G.4 REVISED PMA/510(K) NUMBER AS IT WAS REPORTED INCORRECTLY ON INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-05229. H.3 DEVICE NOT RETURNED SHOULD NOT OF BEEN SELECTED ON INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-05229. WAS THE DEVICE EVALUATED SHOULD NOT HAVE BEEN SELECTED ON INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-05229 AS IT HAS NOT YET BEEN. IF THE DEVICE WAS NOT EVALUATED SELECTION WAS INCORRECT ON INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-05229 AS THE DEVICE WAS RETURNED AND THE INVESTIGATION OF THE DEVICE WAS ANTICIPATED. H.5 REVISED LABEL FOR SINGLE USE AS IT WAS ERRONEOUSLY ENTERED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-05229. H.6 MEDICAL DEVICE PROBLEM CODE WAS REVISED AND COMPONENT CODE WAS ADDED SINCE THE INITIAL SUBMISSION OF MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-05229 IN ACCORDANCE WITH UPDATED PROCEDURES. H.8 REVISED USAGE OF DEVICE AS IT WAS ERRONEOUSLY ENTERED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-05229.

    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. THE COMPLAINANT IN JAPAN HAD A CP SUPPORT IN WHICH WHEN PREPARING THE CASE/STARTING SUPPORT THE (AUTOMATED IMPELLA CONTROLLER) AIC POWERED UP WITH A RED BATTERY FAILURE ALARM. THE CASE WAS COMPLETED WITH THE CP AND THERE WAS NO NOTED HARM OR INJURY FROM ANY DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2160548 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1557944 00813502011814

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male