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

Model Number	C12787
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The black power cord connected to the quantien monitor began to smoke.The procedure was immediately stopped, and the monitor was turned off.The procedure was finished with a non-abbott device.Patient's information (e.G.Age, weight, gender, ethnicity, race, patient's initials) cannot be handled by abbott in absence of patient's written consent as required by the personal data protection national legislation.National legislation prevents the recording of such information.A written consent has not been obtained in this case; therefore, this information is not available.
Additional Manufacturer Narrative
Based on the information provided to abbott and the investigation performed, the root cause of the reported event cannot be conclusively determined as no abnormalities were identified.The returned product operated as designed during the evaluation period.

• 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
• MDR Report Key: 7940394
• Report Number: 2184149-2018-00167
• Device Sequence Number: 2014595
• Product Code: DQK
• UDI-Device Identifier: 05415067000996
• UDI-Public: 05415067000996
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K123984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2019

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: 6049866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/25/2018
• Supplement Date Received by Manufacturer: 01/04/2019
• Initial Report FDA Received Date: 10/05/2018
• Supplement Report FDA Received Date: 01/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention