MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE VELOCITY¿ SYSTEM VELOCITY AMPLIFIER; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number 100014514

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 02/21/2023

Event Type  malfunction  

Manufacturer Narrative

One ensite velocity¿ amplifier was received for evaluation.Power was applied to the amplifier and the amplifier did not initiate the power-on-self-test (post).The amplifier stayed status steady amber ¿not-ready¿ and could not communicate with the test ensite computer.Internal inspection revealed the ic chip on the ampro assembly (part of the micro-processor board) was missing due to an over temperature condition, which duplicated the reported symptom.When the micro-processor board was replaced with a known good processor, the amplifier passed the post and communicated with the test station.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.The reported event was able to be duplicated by power sequencing and internal inspection.Based on the information provided to abbott and the investigation performed, the root cause was attributed to a thermal event on the ampro assembly of the micro-processor board.

Event Description

This report is to advise of a thermal event noted during analysis,.

• Brand Name: ENSITE VELOCITY¿ SYSTEM VELOCITY AMPLIFIER
• 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: 16630627
• MDR Text Key: 312159122
• Report Number: 2184149-2023-00071
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K141050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100014514
• Device Catalogue Number: 100014514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/23/2023
• Initial Date FDA Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2015
• 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