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); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Livanova (b)(4) manufactures the s5 system.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate.The service representative was able to confirm the reported issue and traced the failure to a defective ups module.The technician replaced the module to resolve the reported issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The defective module was returned to livanova (b)(4) for further investigation.During the evaluation the reported issue could be reproduced.Two short circuits on the board could be identified as root cause of the reported issue.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.
Event or Problem Description
Livanova (b)(4) received a report that a s5 system displayed an alarm and the customer reported burning smell after the alarm occurred during procedure.In addition the battery level indicator and percentage became blank there was no report of patient injury.

• Brand Name: S5 SYSTEM
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• MDR Report Key: 7352385
• Report Number: 9611109-2018-00237
• Device Sequence Number: 1556381
• Product Code: DTQ
• UDI-Device Identifier: 04033817900900
• UDI-Public: 010403381790090011161121
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/20/2018

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 Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2018
• Initial Report FDA Received Date: 03/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1