BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PC GEN 2, NON-QSK, STERILE, JAPAN

    MDR report key: 23924909 · Received December 30, 2025

    Report

    Report Number
    1220648-2025-49552
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Date of Event
    December 8, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER; THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT THE LIQUID LEAKED FROM PURGE HOUSING. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2220349 PC GEN 2, NON-QSK, STERILE, JAPAN TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 PC GEN 2, NON-QSK, STERILE, JAPAN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female