BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 17834702 · Received September 28, 2023

    Report

    Report Number
    1220648-2023-03457
    Event Type
    Malfunction
    Date Received
    September 28, 2023
    Date of Event
    August 31, 2023
    Report Date
    August 15, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502010022
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    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.1 ADDED INFORMATION IN ACCORDANCE WITH UPDATED PROCEDURES SINCE THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-03457 WAS SUBMITTED. A.2 AGE SHOULD HAVE BEEN LEFT BLANK IN ACCORDANCE WITH UPDATED PROCEDURES ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-03457 AS NO PATIENT WAS INVOLVED. A.3 NA SHOULD HAVE BEEN SELECTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-03457 AS NO PATIENT WAS INVOLVED. 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 1220648-2023-03457 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 1220648-2023-03457 WAS SUBMITTED. E.2 REVISED SELECTION IN ACCORDANCE WITH UPDATED PROCEDURES SINCE THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-03457 WAS SUBMITTED. G.1 REVISED MDR REPORTING CONTACT EMAIL SINCE THE INITIAL SUBMISSION OF MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-03457 IN ACCORDANCE WITH UPDATED PROCEDURES. ADDED REPORTING CONTACT FAX NUMBER IN ACCORDANCE WITH UPDATED PROCEDURES SINCE THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-03457 WAS SUBMITTED. H.5 AND H.8 REVISED SELECTION AS IT WAS REPORTED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-03457. H.6 CODES 2199 AND 3221 WERE REPORTED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER IN ACCORDANCE WITH UPDATED PROCEDURES. A NEW CODE WAS ADDED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED BIOMED DEPARTMENT FILED A COMPLAINT FOR A FAILED SELF CHECK. THERE WAS NO PATIENT USE OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2037771 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1124694 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown