BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 17769933 · Received September 18, 2023

    Report

    Report Number
    1220648-2023-03239
    Event Type
    Malfunction
    Date Received
    September 18, 2023
    Date of Event
    August 21, 2023
    Report Date
    December 1, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502010022
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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

    A.2 AGE SHOULD HAVE BEEN LEFT BLANK IN ACCORDANCE WITH UPDATED PROCEDURES ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-03239 AS IT IS UNKNOWN. A.3 UNKNOWN SHOULD HAVE BEEN SELECTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-03239 AS IT IS UNKNOWN. 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 1220648-2023-03239 WAS SUBMITTED. D.4 MODEL NUMBER, CATALOG NUMBER AND SERIAL NUMBER WERE REVISED IN ACCORDANCE WITH UPDATED PROCEDURES SINCE THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-03239 WAS SUBMITTED. E.1 NAME PREFIX/TITLE WAS REVISED AS IT WAS PREVIOUSLY ENTERED INCORRECTLY ON INITIAL MANUFACTURER DEVICE REPORT 1220648-2023-03239. G.1 REVISED MDR REPORTING CONTACT EMAIL SINCE THE INITIAL SUBMISSION OF MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-03239 IN ACCORDANCE WITH UPDATED PROCEDURES. H.6 CODES 2199 AND 3221 WERE REPORTED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-03239 IN ACCORDANCE WITH UPDATED PROCEDURES.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE CONTROLLER WAS TURNED ON AND A YELLOW BANNER APPEARED READING CONTROLLER ERROR. THE CONTROLLER WAS EXCHANGED AS A RESULT OF THE NOTED ISSUE. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088574 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1087949 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown