MAUDE Adverse Event Report: ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Model Number	AUTOMATED IMPELLA CONTROLLER
Medical Device Problem Code	Computer Operating System Problem (2898)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event did not involve patient use.Section a was left blank.The impella device was returned, and an evaluation is underway.Upon completion of our analysis, a supplemental report will be filed.
Event or Problem Description
It was reported that the automated impella controller had a self check failure upon start up.The controller was removed from service.There was no patient involvement.
Additional Manufacturer Narrative
H6 type of investigation, investigation findings, investigation conclusions and component codes were updated accordingly based on the completed investigation.Investigation summary: the investigation has been completed.Data analysis: the console logs showed a communication issue with the power battery manager (pbm) during the initial bootup.Due to the communication issue, the automated impella controller console rebooted automatically (as designed) to attempt another power on.After rebooting, the console displayed the "system self check failed" screen, and the console was then forcefully shut down.Device analysis: upon bootup, the console rebooted automatically and showed the "system self check failure" screen.Visual inspection confirmed the pbm contamination which has impacted a neighboring rs232 communication channel.During firmware execution, the sau_powermod_1 hardware revision displayed as ¿n/a¿ and the firmware version also showed ¿n/a.¿ this occurred due to a communication issue between the device and the system.Root cause: the root cause of the ¿system self check failure¿ was determined to be pbm corrosion due to leakage of the electrolyte from the battery failure alarm super caps.Product history review summary: there were no issues related to complaint discovered when reviewing the product history of the console.
Additional Manufacturer Narrative
Medical device removal code was removed from section h.Clinical assessment: none.Engineering assessment: there is no case associated with this complaint.There is no mention of medical device removal, only an issue with the aic starting up and pbm corrosion.

• Brand Name: AUTOMATED IMPELLA CONTROLLER
• Common Device Name: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED, INC.; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 23788573
• Report Number: 1220648-2025-48959
• Device Sequence Number: 20220352
• Product Code: OZD
• UDI-Device Identifier: 00813502011289
• UDI-Public: (01)00813502011289(10)1388684(11)19012
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AUTOMATED IMPELLA CONTROLLER
• Device Catalogue Number: 0042-0000-EU
• Device Lot Number: 1388684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: 02/06/2026; 12/02/2025
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 02/09/2026; 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown