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

Model Number H702475

Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/30/2020

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

During the procedure, the precision link smelled of burning and displayed arcing when powered on.An arced/blackened spot is visible on one of the spots where the 4 pin prong is inserted for power.The cover was taken off the link and no internal damage was noted other than the power connection.There were no adverse consequences to the patient or the user.

Event Description

This was a supraventricular tachycardia procedure.

Manufacturer Narrative

Additional information: b5.One ensite¿ precision¿ link sensor enabled was received for analysis.Inspection of the power inlet connector at the rear of the chassis confirmed, that one of the four pins is discolored or blackened.Functional testing revealed, no communication was able to be established.And a scu processor or logic voltage fault was displayed.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 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
• MDR Report Key: 11132560
• MDR Text Key: 225563888
• Report Number: 2184149-2021-00005
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067024756
• UDI-Public: 05415067024756
• Combination Product (y/n): N
• PMA/PMN Number: K183128
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• 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
• Device Lot Number: 6757435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other