BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA

    MDR report key: 4173621 · Received August 26, 2014

    Report

    Report Number
    4173621
    Event Type
    Malfunction
    Date Received
    August 26, 2014
    Date of Event
    August 3, 2014
    Report Date
    August 26, 2014
    Manufacturer
    ABIOMED, INC.
    Product Code
    KFM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON CHECKED FUNCTION OF IMPELLA 5.0 DEVICE AND FOUND IT WOULD NOT FUNCTION.======================MANUFACTURER RESPONSE FOR IMPELLA 5.0 DEVICE, IMPELLA 5.0 (PER SITE REPORTER).======================RM SPOKE TO MANUFACTURER'S REP. HE ADVISES IT MAY TAKE AS LONG AS 8-10 TO HAVE THE DEVICE ANALYZED AND REPORTED UPON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515899 IMPELLA PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM ABIOMED, INC. IMPELLA 5.0 *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR NO OTHER THERAPIES