MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. QUANTIEN; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number C12787

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2019

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

While performing a ffr case, a burning smell was noted and the power adapter connected to the quantien became burnt.Smoke was noted to be coming from the power adapter and the system shut down.The procedure was completed without ffr with no adverse consequences to the patient or user.The quantien was replaced to resolve the issue.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received and electronic data, the reported incident is verified to have occurred, but the cause could not be determined.

Manufacturer Narrative

One quantien was received into the lab for analysis with no accessories or original packaging available for inspection.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, root cause of the field reported event citing a thermal event was successfully isolated to abnormal functionality of the attached power supply.

• Brand Name: QUANTIEN
• 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: 9590937
• MDR Text Key: 175038542
• Report Number: 2184149-2020-00003
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067000996
• UDI-Public: 05415067000996
• Combination Product (y/n): N
• PMA/PMN Number: K123984
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C12787
• Device Catalogue Number: C12787
• Device Lot Number: 6795768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1