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 08/02/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation results will be provided in a subsequent submission.

Event Description

During hardware set up prior to the procedure, a spark was noted when plugging in the power supply of the precision link.Traces of powder were visible at the connection between the cable and the connector.The procedure was cancelled and rescheduled for a later date.There were no adverse consequences to the patient or user.

Manufacturer Narrative

One ensite¿ precision¿ link sensor enabled was received for analysis.Visual inspection of the returned product confirmed no physical damage was detected on the exterior chassis and all labels were intact, legible and properly oriented.Inspection of the power inlet connector revealed discoloration at one of the electrical contact pins due to an electrical short circuit.The psu (power supply unit) associated with the event was not returned for evaluation.Power was applied to the returned product which initialized as anticipated.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information provided to abbott and the investigation performed, the root cause of the reported spark and subsequent cancellation was isolated electrical arcing at the power inlet connector.

• 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: 8866163
• MDR Text Key: 156910309
• Report Number: 2184149-2019-00145
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067024756
• UDI-Public: 05415067024756
• Combination Product (y/n): N
• PMA/PMN Number: K160210
• 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: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H702475
• Device Lot Number: 5564909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other