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

Model Number	48-30-00
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/04/2018
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 found that several of the touch screen could not be operated.The technician flashed the software and cleared the internal memory of the device to resolve the malfunction.Subsequent functional verification testing was completed without further issues and the unit was returned to service.A serial readout was performed and sent to livanova (b)(4) 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.Evaluated on site by livanova technician.
Event or Problem Description
Livanova (b)(4) received a report that the touch screen of an s5 system became unresponsive during a procedure.The user also reported that the pump stopped.There was no report of patient injury.
Additional Manufacturer Narrative
Previously, complaints related to the firmware were considered to be reportable malfunctions.However, as the display and control module is part of the system panel, which is the interface between the user and the perfusion system, the module only displays sensor data, time measurements and status messages.It is partially used for the alarm management, configuring and assigning monitoring functions and providing information to the ups module.The module is not used for configuring and controlling the pumps themselves.The reported malfunction would not have any affect on device performance or the ability to maintain blood flow during cardiac surgery.Consequently, livanova (b)(4) was unable to identify a hazardous situation potentially leading to a serious injury as a result of this type of issue, and it is now considered to be non-reportable.

• 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: 7466897
• Report Number: 9611109-2018-00937
• Device Sequence Number: 1543020
• Product Code: DTQ
• UDI-Device Identifier: 04033817900887
• UDI-Public: 010403381790088711171120
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 06/18/2018

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: 48-30-00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/04/2018
• Supplement Date Received by Manufacturer: 05/23/2018
• Initial Report FDA Received Date: 04/26/2018
• Supplement Report FDA Received Date: 06/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1