MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 SYSTEM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	48-50-00
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided.Livanova (b)(4) manufactures the s5 system.The incident occurred in (b)(6).If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova (b)(4) received a report that a burning smell was generated from an s5 system after about 45 minutes after the start of the battery test.The machine was turned off.There was no report of user injury.
Additional Manufacturer Narrative
Through follow-up communication livanova (b)(4) learned, that the reported malfunction was fixed by replacing an internal circuit board.Visual inspection showed burnt components, of which pictures have been provided.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The reported error message and following burning smell likely to cause or contribute to death or serious injury to the patient, as the malfunction affected a non-clinical functionality of the device.Based on the new information, the defective component could not lead to any hazardous situation for the user, following its burning.According to the above, the event has been re-evaluated as non reportable.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
See initial report.

• Brand Name: S5 SYSTEM
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 8517089
• Report Number: 9611109-2019-00252
• Device Sequence Number: 1515329
• Product Code: DTQ
• UDI-Device Identifier: 04033817900900
• UDI-Public: 010403381790090011181126
• Combination Product (Y/N): N
• Initial Reporter Country: AG
• PMA/510(K) Number: K071318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2019

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: 48-50-00
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 07/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1