MAUDE Adverse Event Report: ABBOTT MEDICAL ENSITE¿ X AMPLIFIER; Computer, diagnostic, programmable

Model Number	ENSITE-AMP-02
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One ensite x amplifier was received for evaluation at tech center.Visual inspection revealed the front ports, rear ports, and chassis show signs of wear consistent with use over time.The front panel was tested for electrical leakage using a digital voltage meter.There was no active volt energy detected to any of the metallic rings to the front plane (isolated).The port connectors for the advisor catheter are also isolators and have no electrical current.The advisor was connected to each port (4, 7, and 8) with no em (electro or magnetic) events.By design the active lines have 500 ohm resistance between them and by design would not create a potential.All testing was done at power-on state, and power-applied in off-state, and non-power connected off-states.The field reported event was not able to be duplicated.Evaluation testing was successful.Based on the information provided to abbott and the investigation performed, the reported event was not able to be confirmed, and the root cause remains undetermined as the amplifier passed all testing.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 the procedure, it was noted that the tech was "shocked" when the hd grid was connected to the amplifier.The tech was not injured and no intervention was required.

• Brand Name: ENSITE¿ X AMPLIFIER
• Common Device Name: Computer, diagnostic, programmable
• 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 n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23513188
• Report Number: 2184149-2025-00180
• Device Sequence Number: 9733310
• Product Code: DQK
• UDI-Device Identifier: 05415067034755
• UDI-Public: (01)05415067034755(10)8235841
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K242016
• 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): 11/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ENSITE-AMP-02
• Device Catalogue Number: ENSITE-AMP-02
• Device Lot Number: 8235841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2025
• 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: 10/15/2025
• Initial Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown