MAUDE Adverse Event Report: ABBOTT MEDICAL AMPERE¿ RF ABLATION GENERATOR; Cardiac ablation percutaneous catheter

Model Number	H700488
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One ampere¿ rf ablation generator was received for analysis.When ac power was applied to the generator, the screen failed to illuminate and no boot sequence was observed, confirming the reported event.Inspection of the power supply fuses confirmed both fuses were intact.Temporarily replaced the power supply board with a known good board assembly and power was reapplied to the system, upon which a normal boot sequence was observed, and normal function was restored to the unit.Based on the information provided to abbott and the investigation performed, root cause of the field reported event was isolated to abnormal functionality of the power supply board assembly.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.
Event or Problem Description
During patient preparation for a procedure, it was noted that the ampere generator would not boot up.The procedure was then cancelled.

• Brand Name: AMPERE¿ RF ABLATION GENERATOR
• Common Device Name: Cardiac ablation percutaneous catheter
• Manufacturer (Section D): ABBOTT MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ABBOTT MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23698433
• Report Number: 2184149-2025-00203
• Device Sequence Number: 10231813
• Product Code: LPB
• UDI-Device Identifier: 05415067004888
• UDI-Public: (01)05415067004888(10)5660333
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P110016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/02/2025

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: H700488
• Device Catalogue Number: H700488
• Device Lot Number: 5660333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2014
• 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