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

Model Number H702475

Device Problem Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

While connecting the precision link power cable to the power outlet sparks were detected.Black residue was observed on the power supply.There were no patient or user adverse consequences due to the spark and the precision link was not used for the procedure.

Manufacturer Narrative

Additional information: g4, g7, h2, h3, h6; the results of the investigation are inconclusive since the device was not returned for analysis.The device was replaced at the facility and is no longer in use.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.Based on the information received, the cause of the reported spark could not be conclusively determined.

• 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: 9747040
• MDR Text Key: 190933110
• Report Number: 2184149-2020-00027
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• 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: 5491819
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1