MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE PRECISION POWER CABLE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number 100143451

Device Problem Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Date 12/13/2019

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 set up for a procedure the ensite precision link power supply cable fell apart and sparked.A different power supply was utilized for the scheduled procedure.There were no user consequences.

Manufacturer Narrative

One ensite precision¿ power supply unit 4 was received.Visual inspection of the returned power supply module confirmed the reported spark as the four pin redel connector has been separated from the outer shell.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 provided to abbott and the investigation performed, the root cause of the reported spark was isolated to a detached redel connector body.

• Brand Name: ENSITE PRECISION POWER CABLE
• 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: 9531935
• MDR Text Key: 191763507
• Report Number: 2184149-2019-00258
• 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: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100143451
• Device Catalogue Number: H702475
• Device Lot Number: 6859138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1