BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 20698512 · Received November 15, 2024

    Report

    Report Number
    1220648-2024-23251
    Event Type
    Malfunction
    Date Received
    November 15, 2024
    Date of Event
    October 29, 2024
    Report Date
    August 14, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011401
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    A.1 ADDED INFORMATION AS IT WAS INADVERTENTLY OMITTED FROM INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-23251. A.2 AGE SHOULD HAVE BEEN LEFT BLANK ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-23251 AS NO PATIENT WAS INVOLVED. A.3 REVISED AS SELECTION WAS PREVIOUSLY ENTERED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-23251. D.1 BRAND NAME AND D.2 COMMON DEVICE NAME WERE REVISED AS THEY WERE PREVIOUSLY ENTERED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-23251. D.4 MODEL NUMBER AND SERIAL NUMBER WERE REVISED AS THEY WERE PREVIOUSLY ENTERED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-23251. E.2 AND E.3 REVISED AS SELECTIONS WERE PREVIOUSLY ENTERED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-23251. E.4 SHOULD HAVE BEEN LEFT BLANK ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-23251 AS IT IS UNKNOWN IF THE INITIAL REPORTER ALSO SENT THE REPORT TO THE FOOD AND DRUG ADMINISTRATION. G.1 REVISED MDR REPORTING CONTACT EMAIL AS IT WAS ENTERED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-23251. H.6 CODES 3221 AND 2199 WERE ENTERED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2024-23251. CODE 2645 WAS ADDED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT THE AUTOMATED IMPELLA CONTROLLER (AIC) HAD A CONTROLLER ERROR ALARM. THE AIC WAS REMOVED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1335705 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1752855 00813502011401

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown