MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE¿ PRECISION¿ LINK SENSOR ENABLED; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	H702475
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This report is to advise of an event observed during analysis confirming two discolored/blackened pins which was isolated to an electrical arc at the rear power inlet connector.
Additional Manufacturer Narrative
One ensite precision link sensor enabled was received for analysis with no accessories or original packaging available for inspection.Visual inspection of the returned device revealed the fiber com board was observed to have two discolored/blackened pins.The two discolored/blackened pins was isolated to an electrical arc at the rear power inlet connector.Root cause of the observed damage remains undetermined.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.

• Brand Name: ENSITE¿ PRECISION¿ LINK SENSOR ENABLED
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13591638
• Report Number: 2184149-2022-00054
• Device Sequence Number: 14907871
• Product Code: DQK
• UDI-Device Identifier: 05415067024756
• UDI-Public: 05415067024756
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K183128
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/24/2022

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: H702475
• Device Catalogue Number: H702475
• Device Lot Number: 6344643
• 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: 02/18/2022
• Initial Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2017
• 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