BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA CP

    MDR report key: 23888943 · Received December 24, 2025

    Report

    Report Number
    1220648-2025-49326
    Event Type
    Malfunction
    Date Received
    December 24, 2025
    Date of Event
    October 1, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO PRODUCT WAS RETURNED. DEVICE IN WRONG POSITION (POSITIONING ISSUE): THE CAUSE OF THE POSITIONING ISSUE WAS DETERMINED TO BE AN UNINTENTIONAL USE ERROR AS THE PUMP BECAME DISLODGED WHEN THE RN ACCIDENTALLY SAT PT UP IN BED. DEVICE HISTORY LOT: DEVICE LOT: 1870336. DEVICE HISTORY BATCH: SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW: DEVICE (SN: (B)(6)) PASSED ALL POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA CP FOR MECHANICAL CIRCULATORY SUPPORT. DURING SUPPORT, THE NURSE ACCIDENTLY SAT THE PATIENT UP IN BED AND THIS CAUSED THE IMPELLA TO BECOME DISLODGED. THE DEVICE WAS REPLACED WITH ANOTHER IMPELLA CP. IT WAS REPORTED THAT THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1919434 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2025594240 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male