BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 20189954 · Received September 11, 2024

    Report

    Report Number
    1220648-2024-17628
    Event Type
    Malfunction
    Date Received
    September 11, 2024
    Date of Event
    August 14, 2024
    Report Date
    October 4, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011401
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON COMPLETION OF OUR ANALYSIS, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE CONSOLE (AIC) ALARM MALFUNCTIONS AND SHUTDOWN ISSUES HAS BEEN COMPLETED. CONSOLE LOGS FROM THE REPORTED DAY OF EVENT SHOW AN UNEXPECTED SHUTDOWN AND RESTART OF THE CONSOLE, FOLLOWED BY ¿UNEXPECTED SHUTDOWN¿ ALARM AND PRECEDED BY AN ONSET OF PUD COMMUNICATION FAILURES, THAT WERE NOT RESOLVED AFTER PUD RESETS. THE CONSOLE WAS RETURNED FOR EVALUATION FINDING THAT THE ISSUE WAS NOT REPRODUCED. THERE WAS NO NOISE (FROM PBM OR ANYWHERE ELSE), NO UNEXPECTED RESTARTS, OR ALARMS. INSPECTION OF THE WIRING INSIDE THE CONSOLE, HOWEVER, REVEALED LOOSE CONNECTOR OF THE CABLE IN J16 SOCKET ON THE PBM BOARD. THIS CONNECTION SUPPLIES VOLTAGE TO PUD VIA 4-IN-1 CARRIER, VOLTAGE TO EPC, AND GND FOR PUD AND EPC. OBSERVED SYMPTOMS DESCRIBED IN THE COMPLAINT ARE CONSISTENT WITH INTERMITTENT LOSS OF ELECTRICAL CONNECTION AT THIS PORT, AND THE REPORTED NOISE MIGHT HAVE BEEN RELATED TO INTERMITTENT OPERATION OF THE PURGE MOTOR, RATHER THAN PBM BOARD BUZZER. LOOSE CONNECTOR WAS MOST LIKELY RESULT OF AN ERROR DURING ONE OF PRIOR PM OR FC PROCEDURES OF THE LOANER IC9502. ADDED- H6 COMPONENT CODE 4733.

    Description of Event or Problem · 0

    THE AUTOMATED IMPELLA CONTROLLER (AIC) WAS IN FOR SERVICE AND FOUND TO HAVE A MALFUNCTION. THE AIC WAS NOISY AND KEPT RESTARTING DURING THE CONSOLE CHECK. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1510977 AUTOMATED IMPELLA CONTROLLER CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1637920 00813502011401

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown