MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE PRECISION MODULE, SENSOR ENABLED (US); COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	H702470
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During device preparation, when powered on, sparking was noted.The system was replaced and the procedure was completed with no adverse patient consequences.
Additional Manufacturer Narrative
One ensite¿ precision¿ link sensor was received into the lab for analysis. inspection of the power inlet connector at the rear of the chassis confirmed the field reported issue as one of the four pins is discolored or blackened.The psu (power supply unit) in use at the time of the reported event was not returned for evaluation.Functional testing was performed to ensure communication and accurate positions were actively tracked within the magnetic acquisition area.All catheter ports and patient reference sensor ports were tested.No error messages or communication drops were displayed during the evaluation period.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined that no non-conformances were identified that are related to the reported event.Based on the information provided to abbott and the investigation performed, the root cause of the field reported issue was isolated to an electrical arc at the rear power inlet connector from an undetermined event.

• Brand Name: ENSITE PRECISION MODULE, SENSOR ENABLED (US)
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 12247785
• Report Number: 2184149-2021-00219
• Device Sequence Number: 3112546
• Product Code: DQK
• UDI-Device Identifier: 05415067024701
• UDI-Public: 05415067024701
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2021

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: H702470
• Device Catalogue Number: H702470
• Device Lot Number: 5862250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1