MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 AUTOMATED IMPELLA CONTROLLER; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Model Number	AUTOMATED IMPELLA CONTROLLER
Medical Device Problem Codes	Computer Operating System Problem (2898); Operating System Becomes Nonfunctional (2996)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during customer training the automated impella controller screen froze.There was no patient involvement.
Additional Manufacturer Narrative
The event did not occur with a patient.Section a was left blank.The impella device was not received from the customer; therefore, investigation of the device was not possible.Should the device or any new information be received, a supplemental mdr will be filed.
Additional Manufacturer Narrative
Correction: d1, h5, and h8 was erroneously entered on the initial manufacturer device report.D4 was inadvertently omitted on the initial manufacturer device report.
Additional Manufacturer Narrative
The investigation for the controller/device freezes issue has been completed.The device and data logs were returned for evaluation.The logs showed that in the case start wizard at step three, the pump connection was most likely not recognized, or the white catheter plug was not completely inserted into the aic, so after 20 seconds, epm was reset automatically.After the epm reset, the pump connection remained unrecognized, confirming the reported failure mode.This could be most likely due to the crystal issue on the impellatronic (epm) board.Subsequently, the soft button next was pressed, causing the console to display messages indicating ¿connect cable: detecting impella screen¿ and ¿connect cable: connect grey connectors screen.¿ the console was evaluated and during testing, the pump detection issue could not be reproduced despite several attempts to connect a known-good impella and power cycling the console in between attempts.The root cause of the aic screen freezing during customer training, where the demo case did not proceed was likely due to the rarely occurring epm crystal startup issue.The impellatronic pca does not have permanent damage, but this intermittent pump detection failure occurs infrequently and has a sw mitigation in place.
Additional Manufacturer Narrative
H6: added code based on information in the complaint file.

• Brand Name: AUTOMATED IMPELLA CONTROLLER
• Common Device Name: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED, INC. - 1220648; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 23888673
• Report Number: 1220648-2025-49310
• Device Sequence Number: 20001523
• Product Code: OZD
• UDI-Device Identifier: 00813502011289
• UDI-Public: (01)00813502011289(10)1319196(11)180116
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/10/2026

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: 1319196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2025
• Supplement Date Received by Manufacturer: 12/30/2025; 09/05/2025; 02/04/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 01/05/2026; 02/02/2026; 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2018
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: MWR-02122025-0001983438
• Patient Sequence Number: 1
• Patient Sex: Unknown