BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 20654157 · Received November 11, 2024

    Report

    Report Number
    1220648-2024-22896
    Event Type
    Malfunction
    Date Received
    November 11, 2024
    Date of Event
    May 27, 2022
    Report Date
    November 11, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502010022
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE REPORTED ISSUE HAS BEEN COMPLETED. THE PRODUCT WAS RETURNED, AND THE ISSUE WAS NOT CONFIRMED. CONSOLE LOGS FROM THE REPORTED DAY OF EVENT ARE CONSISTENT WITH COMPLAINT AND SHOW CONTROLLER ERROR ALARM (#24) DUE TO KBD COMM LOSS, UPON CONSOLE BOOT-UP. THIS IS PRECEDED BY COMMUNICATION ERROR (IMC-KBD ERROR: 0XA4 0X01 0X00), AND THE FACT THAT CONSOLE¿S BOOT-UP COUNT WAS NOT CONSECUTIVE, INDICATING PRIOR FAILED BOOT-UP SEQUENCE: AFTER CONSOLE WAS MANUALLY POWER-CYCLED, THE ISSUE DID NOT RE-OCCUR. CONSOLE WAS TESTED IN DANVERS, AND POWER-CYCLED SEVERAL TIMES, BUT THE ISSUE WAS NOT REPRODUCED. HOWEVER, THIS IS A KNOWN RARE PATTERN FAILURE WHICH RESULTS FROM MOMENTARY COMMUNICATION BREAKDOWN DURING INITIALIZATION OF KBD TO 4-IN-1 COMMUNICATION. THIS ISSUE COULD BE CAUSED BY EITHER OF THE COMMUNICATING DEVICES/MICROPROCESSORS: MSC1210 ON THE 4-IN-1 OR AT42QT1060 ON THE KBD ASSEMBLY. A COMPROMISED RIBBON CABLE BETWEEN THESE TWO DEVICES IS ALSO A PLAUSIBLE CAUSE. THE CAUSE OF THE ISSUE WAS NOT DETERMINED SINCE ISSUE WAS UNABLE TO BE REPRODUCED. THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED FOR AN AUTOMATED IMPELLA CONTROLLER (AIC) THAT THERE WAS A CONTROLLER ERROR ALARM DURING PREPARATION OF THE DEVICE. A NEW CONSOLE WAS USED WITH NO ADVERSE IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1721414 AUTOMATED IMPELLA CONTROLLER CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1200770 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male