BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 20024894 · Received August 22, 2024

    Report

    Report Number
    1220648-2024-15616
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    May 19, 2023
    Report Date
    August 18, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502010022
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE AIC KBD/NOTARY ISSUES HAS BEEN COMPLETED. CONSOLE LOGS FROM THE REPORTED DAY OF EVENT ARE CONSISTENT WITH COMPLAINT AND SHOW CONTROLLER ERROR ALARM (#24, DUE TO LOSS OF COMMUNICATION WITH KBD), PRECEDED BY KBD ERROR MESSAGE ¿IMC-KBD ERROR: 0XA4 0X01 0X00¿, WHICH TRANSLATES TO ¿KEYBOARD READ FAILURE OF CHIP_ID)¿. THE ISSUE DID NOT RE-OCCUR UPON NEXT BOOT-UP. THE AIC WAS RETURNED FOR EVALUATION FINDING THAT I2C COMMUNICATION BETWEEN KBD CONTROLLER (ATMEL QT1060) AND MSC1210 MICROCONTROLLER ON THE 4-IN-1 CARRIER WAS MONITORED AND ANALYZED. WE WERE ABLE TO REPRODUCE THE ISSUE, UPON ONE OF CONSOLE¿S BOOT-UPS: DURING INITIAL POWER-UP SEQUENCE, THE I2C CLOCK (SCL) FAILED TO INITIALIZE AND WAS KEPT IN ¿LOW¿ STATE, DESPITE DATA (SDA) CHANNEL BEING ACTIVE. IT¿S BEEN OBSERVED THAT AT THE SAME TIME THE ROTARY PUSH-BUTTON (RPB) WAS UNRESPONSIVE (MSC1210 ON 4-IN-1 CARRIER PROCESSES SIGNALS FROM RPB). WHEN KBD COMMUNICATION CABLE WAS DISCONNECTED AND RECONNECTED (POWER-CYCLING THE KBD CONTROLLER), THE ISSUE WAS NOT RESOLVED. ALL THIS INDICATES THAT IT WAS THE MICROCONTROLLER THAT MALFUNCTIONED. DURING CONSOLE INSPECTION WE OBSERVED THAT PURGE DISK RETAINER WAS CRACKED AND MOUNTING SCREWS FOR THE BATTERY BRACKET WERE LOOSE. THIS REPORT IS BEING FILED AS A PART OF THE RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER REPORTED THAT THE CONSOLE (AIC) FAILED. THE CONSOLE WAS SWAPPED FOR LOANER CONSOLE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1397512 AUTOMATED IMPELLA CONTROLLER CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1100958 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown