MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 CONTROL PANEL MRP 150/85; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	28-95-80
Medical Device Problem Codes	Loss of Power (1475); Pumping Stopped (1503)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Livanova (b)(4) manufactures the s5 control panel mrp.The incident occurred in (b)(6).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.Device not returned.
Event or Problem Description
Livanova (b)(4) received a report that an s5 control panel mrp lost power during priming.This power loss led to a stop of the mast roller pump.The customer restarted the s5 system to resolve the reported issue.However, the reported failure recurred when switching to another device.There was no patient involvement.
Additional Manufacturer Narrative
The mast pump and processor board were returned to livanova (b)(4) for further investigation.The devices were intensively tested without finding malfunctions.The devices worked according to the specification.As the issue was not reproduced or confirmed, a root cause could not be identified.

• Brand Name: S5 CONTROL PANEL MRP 150/85
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• MDR Report Key: 7728983
• Report Number: 9611109-2018-01113
• Device Sequence Number: 1015534
• Product Code: DWB
• UDI-Device Identifier: 04033817900818
• UDI-Public: 010403381790081811161027
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 11/06/2018

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: 28-95-80
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/30/2018
• Supplement Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 07/27/2018
• Supplement Report FDA Received Date: 11/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1