BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA

    MDR report key: 24845246 · Received April 10, 2026

    Report

    Report Number
    1220648-2026-06621
    Event Type
    Malfunction
    Date Received
    April 10, 2026
    Date of Event
    April 3, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502010022
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A4 WEIGHT 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. RELATED MEDICAL DEVICE REPORTS: THIS AUTOMATED IMPELLA CONTROLLER DEVICE REPORT IS ONE OF TWO DEVICES ASSOCIATED WITH THE EVENT. REFER TO THE RELATED MANUFACTURER REPORT NUMBER AS NOTED IN SECTION H10 FOR THE MEDICAL DEVICE REPORT ON THE IMPELLA CP.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT DURING MECHANICAL CIRCULATORY SUPPORT, A "PLACEMENT SIGNAL NOT RELIABLE" ALARM WAS OBSERVED UPON INITIATION OF IMPELLA FLOW. AT THE TIME OF THE EVENT, TWO IMPELLA DEVICES WERE ASSOCIATED WITH THE PATIENT: AN IMPELLA CP DEVICE (SERIAL NUMBER (B)(6)) AND AN AUTOMATED IMPELLA CONTROLLER (AIC) (SERIAL NUMBER (B)(6)). THE PUMP WAS OPERATING IN AUTO MODE WITH AVERAGE REPORTED FLOWS OF APPROXIMATELY 3.8 L/MIN. NO ABNORMALITIES WERE REPORTED WITH THE PLACEMENT WAVEFORM, MOTOR CURRENT, FLOW, OR OTHER DISPLAYED PERFORMANCE METRICS. THE COMPLAINANT INDICATED THAT THE CAUSE OF THE ALARM WAS UNCLEAR AND MAY HAVE BEEN RELATED TO ECTOPIC BEATS; HOWEVER, IT WAS NOT DETERMINED WHETHER THE ALARM WAS ATTRIBUTABLE TO THE CATHETER OR THE CONTROLLER. THE ALARM RESOLVED ON ITS OWN APPROXIMATELY ONE HOUR INTO THE CASE WITHOUT INTERVENTION. WHEN THE ALARM RESOLVED, NO CHANGES IN WAVEFORMS OR OTHER DEVICE METRICS WERE NOTED. THERE WERE NO REPORTS OF PATIENT INJURY, CLINICAL DETERIORATION, OR ADVERSE PATIENT OUTCOME ASSOCIATED WITH THIS EVENT. THE DEVICE WAS SUBSEQUENTLY EXPLANTED SUCCESSFULLY AFTER WEANING. THE EXPLANT WAS NOT CONSIDERED PREMATURE AND WAS UNRELATED TO THE REPORTED EVENT. THE PATIENT'S OUTCOME AT THE TIME OF EXPLANT WAS SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899659 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 1147992 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female