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

Model Number	48-50-00
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Livanova (b)(4) manufactures the s5 system.The incident occurred in (b)(6).A livanova representative went on site and was able to confirm the reported issue.The technician traced the failure back to defective internal and external communication boards.Both boards were replaced to resolve the reported issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.Both boards were requested back for further investigation.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.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 s5 system panel does not power on during procedure.There was no report of patient injury.
Additional Manufacturer Narrative
The boards were returned to livanova (b)(4) for further investigation.During the evaluation the reported failure could be confirmed.As root cause non conform soldering joints could be identified.This is a known issue and a corrective action was initiated for the reported issue.

• 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: 7688959
• Report Number: 9611109-2018-01088
• Device Sequence Number: 19493876
• Product Code: DTQ
• UDI-Device Identifier: 04033817900900
• UDI-Public: 010403381790090011170912
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 08/09/2018

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: 07/10/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/17/2018
• Supplement Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 07/16/2018
• Supplement Report FDA Received Date: 08/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1