BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 17785419 · Received September 20, 2023

    Report

    Report Number
    1220648-2023-03291
    Event Type
    Malfunction
    Date Received
    September 20, 2023
    Date of Event
    August 23, 2023
    Report Date
    August 15, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE AUTOMATED IMPELLA CONTROLLER (AIC) CONTROLLER WAS RECEIVED FOR EVALUATION. UPON INVESTIGATION COMPLETION, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 0

    D.1 AND D.2 BRAND NAME AND COMMON DEVICE NAME WERE REVISED IN ACCORDANCE WITH UPDATED PROCEDURES SINCE THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-03291 WAS SUBMITTED. D.4 MODEL NUMBER AND SERIAL NUMBER WERE REVISED IN ACCORDANCE WITH UPDATED PROCEDURES SINCE THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-03291 WAS SUBMITTED. E.1 REVISED ADDRESS LINE1, US CITY AND US ZIP CODE AS THEY WERE ENTERED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-03291. G.1 REVISED MDR REPORTING CONTACT EMAIL SINCE THE INITIAL SUBMISSION OF MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-03291 IN ACCORDANCE WITH UPDATED PROCEDURES. ADDED REPORTING CONTACT FAX NUMBER IN ACCORDANCE WITH UPDATED PROCEDURES SINCE THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-03291 WAS SUBMITTED. H.6 CODES 2199 AND 3221 WERE REPORTED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-03291 IN ACCORDANCE WITH UPDATED PROCEDURES. H.8 REVISED USAGE OF DEVICE AS IT WAS REPORTED INCORRECTLY ON INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-03291.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A CONTROLLER FAILURE, RED ALARM OCCURRED. THE NURSE SWAPPED OUT THE AUTOMATED IMPELLA CONTROLLER (AIC) WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88825 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1729761

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male