BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 23888926 · Received December 24, 2025

    Report

    Report Number
    1220648-2025-49317
    Event Type
    Malfunction
    Date Received
    December 24, 2025
    Date of Event
    September 26, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502011401
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DHR: Q1) SERVICE HISTORY REVIEW - ARE THERE ANY QNS ASSOCIATED WITH THE COMPLAINT DEVICE¿S MOST RECENT SERVICE REPORT? NO. Q2) SUBCOMPONENT LOT REVIEW - WERE THERE ANY OTHER PRODUCT MALFUNCTION COMPLAINTS IN THIS SUBCOMPONENT LOT RELATED TO THIS FAILURE MODE?. Q3) COMPLAINT HISTORY REVIEW - HAVE THERE BEEN ANY OTHER COMPLAINTS AGAINST THIS CONSOLE? YES. THERE WERE 6 OTHER COMPLAINTS MADE AGAINST THIS CONSOLE: 21-05015-1: PUMP RECOGNITION ISSUE. DETERMINED TO BE DUE TO SOFTWARE. SW V8.4.1 TO V8.5 SHOULD HAVE RESOLVED THE ISSUE. . 21-05256-1: SCROLLING VIDEO ON IMPELLA CONNECT? NO PROBLEM FOUND. BACKSTRAP CABLE REPLACED AS A PRECAUTION. 22-11591-1: UNEXPECTED SHUTDOWN. NOT DETERMINED DUE TO THE INABILITY TO REPRODUCE. 4-IN-1 AND COMPACT FLASHCARDS WERE REPLACED. 23-15053-1: PURGE DISC DETECTION ISSUES. BROKEN PURGE DISC FLAG. REPLACED TO ADDRESS THE ISSUE. 23-16640-1: CONTROLLER FAILURE. THE PURGE HAD A DAMAGED COMMUNICATION PACKET CAUSING AN INCORRECT CRC RESULTING IN A PUD FAILURE ALARM. 25-42086-2: CONSOLE UNABLE TO BOOT SUCCESSFULLY. CORRUPTED COMPACT FLASH CARDS WERE THE ROOT CAUSE. PHR SUMMARY: THERE WAS AN ISSUE RELATED TO THE COMPLAINT DISCOVERED WHEN REVIEWING THE PRODUCT HISTORY OF CONSOLE (B)(6) PRIOR COMPLAINT WITH THE SAME FM/RC (23-15053-1). DATA REVIEW: CONSOLE LOGS WERE CONSISTENT WITH WHAT WAS REPORTED IN THE COMPLAINT. PURGE DISC NOT DETECTED ALARMS [EVENT SET #402] WERE OBSERVED IN THE IMC LOGS FROM THE REPORTED COMPLAINT DATE. (SEE (B)(6)_IMCLOG_SEGMENT.PDF¿ IN THE ATTACHMENTS) DEVICE ANALYSIS: CONSOLE WAS TESTED AFTER ARRIVING IN FIELD SERVICE. THE REPORTED PURGE DISC DETECTION ISSUE WAS ABLE TO BE REPRODUCED. INSPECTION OF THE CONSOLE REVEALED THAT THE PURGE DISC FLAG WAS BROKEN (MISSING AT BLUE RETAINER). (SEE ¿(B)(6)_BROKENPURGEDISCFLAG.PNG¿ IN THE ATTACHMENTS) CONCLUSION: THE ROOT CAUSE OF THE REPORTED PURGE DISC DETECTION ISSUE WAS THE OBSERVED BROKEN PURGE DISC FLAG. REPAIR: BEFORE SENDING THIS CONSOLE BACK TO THE CUSTOMER, FIELD SERVICE WAS INSTRUCTED THE FOLLOWING: - REPLACE THE PURGE DISC DETECT FLAG [3001198] AND PURGE FLAG SPRING [3001196] - PERFORM SECTIONS 10-12 OF PM PROCEDURE (B)(6) - PERFORM A FULL FUNCTIONAL CHECK ON THE CONSOLE AND OPTICAL SYSTEM [0042-7316].

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT DURING CLINICAL USE OF THE AUTOMATED IMPELLA CONTROLLER, THE PURGE DISC WAS NOT DETECTED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1918471 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 AUTOMATED IMPELLA CONTROLLER 1445594 00813502011401

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown