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

Model Number	C12787
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One quantien was received for analysis.Visual inspection found all labeling and input/output connectors to be free of physical damage.The unit was found to be coated in an unknown waxy, yellow material.The device was plugged in and smoke immediately began coming from the power supply brick.The unit was unplugged and the power supply brick was opened.Signs of a thermal event were identified at the input port on the power supply brick.The device was opened and the power supply was bypassed with a known good power supply.The unit powered on successfully when attempted.The reported complaint was confirmed.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.Based on the information received and the investigation performed, the cause for the reported event was isolated to the power supply input port.
Event or Problem Description
This report is to advise of a thermal event noted during analysis.

• Brand Name: QUANTIEN
• Common Device Name: 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: 14285709
• Report Number: 2184149-2022-00114
• Device Sequence Number: 6256323
• Product Code: DQK
• UDI-Device Identifier: 05415067000996
• UDI-Public: 05415067000996
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K123984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/04/2022

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
• Operator of Device: Health Professional
• Device Model Number: C12787
• Device Catalogue Number: C12787
• Device Lot Number: 5530791
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2022
• Initial Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown