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

Model Number	28-98-80
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Livanova (b)(4) manufactures the s5 ups module.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).A livanova field service representative was dispatched to the facility to investigate.The service representative was able to confirm the reported issue.The technician replaced the batteries, the hud board, the dc/dc module and the ups module to resolve the issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The board, dc/dc module and ups module were returned to livanova (b)(4) for further evaluation.During the investigation, a faulty resistor and a faulty capacitor were identified on the hus board.These faulty components were determined to be the root cause of the reported issue.The board will be scrapped and the dc/dc and ups modules will be returned to the customer.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 an s5 ups module was found to be faulty when the device was started during setup.If the device was switched to ups mode, the display module would turn on and off.There was no patient involvement.

• Brand Name: S5 UPS MODULE
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• MDR Report Key: 6881062
• Report Number: 9611109-2017-00738
• Device Sequence Number: 712499
• Product Code: DTQ
• UDI-Device Identifier: 04033817901259
• UDI-Public: 010403381790125911170413
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 09/20/2017

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: 28-98-80
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2017
• Initial Report FDA Received Date: 09/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1