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

Model Number H702475

Device Problem Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/26/2022

Event Type  malfunction  

Event Description

During the procedure, after plugging in the precision link, an audible pop was heard and the unit started to smoke/smell as if it was burning.A second link was used to continue the case with no harm to the patient.

Manufacturer Narrative

Additional information: d9, g3, h2, h3 one ensite¿ precision¿ link sensor enabled was received for analysis.The unit was disassembled, and it was observed there was two screws that hold the fan lying inside the unit.No burnt or charred boards were observed.The unit did not have a burnt smell to it.Power was applied to the link, the unit completed power-on-self-test (post) and then device booted to the application successfully.However, communication could not be established.The system controller unit (scu) board was temporarily replaced with a known-good unit and functionality was restored.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.Based on the investigation and information provided to abbott, root cause of the field reported event was unable to be determined.No hardware abnormalities that would have resulted in the reported event were identified.

• Brand Name: ENSITE¿ PRECISION¿ LINK SENSOR ENABLED
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15505313
• MDR Text Key: 305605119
• Report Number: 2184149-2022-00238
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183128
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H702475
• Device Catalogue Number: H702475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1