BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA AUTOMATIC CONTROLLER

    MDR report key: 24865800 · Received April 13, 2026

    Report

    Report Number
    1220648-2026-06720
    Event Type
    Malfunction
    Date Received
    April 13, 2026
    Date of Event
    April 8, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502011401
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: THE PATIENT INFORMATION IS UNKNOWN E: THE INITIAL REPORTER'S NAME AND CONTACT INFORMATION IS UNKNOWN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ABIOMED INC, OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ABIOMED INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. WHEN ATTEMPTING TO START THE AIC¿, IT WAS DETERMINED THAT THE BATTERY WAS 0% CHARGED. WHEN ASKED BY THE FIELD TEAM WHETHER THE AIC WAS CONTINUOUSLY CONNECTED TO THE POWER SUPPLY, THIS WAS DENIED. WHEN SWITCHING THE ON/OFF SWITCH AND RECONNECTING TO THE POWER SUPPLY, THE BATTERY LEVEL REMAINED AT 0%. SEVERAL LOADING TESTS WERE CARRIED OUT IN CONSULTATION WITH THE FIELD TEAM BY TELEPHONE, BUT WITHOUT SUCCESS. WHEN THE CONSOLE IS DISCONNECTED FROM POWER, IT SHUTS DOWN IMMEDIATELY. A BATTERY CHARGE IS NOT POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926623 IMPELLA AUTOMATIC CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 1933943 00813502011401

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown