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

Model Number	28-95-10
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Livanova (b)(4) manufactures the s5 display- and control module.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 a s5 display- and control module touch screen became unresponsive during in-service.There was no patient involvement.
Additional Manufacturer Narrative
Initially this event was considered to be a reportable event.However due to further investigation it was found that the malfunction of the display module does not affect the performance of the device to maintain the blood flow during the cardiac surgery procedure.Consequently we could not identify a hazardous situation leading to a serious injury for a defect display module.Therefore the event was now considered as non-reportable.

• Brand Name: S5 DISPLAY- AND CONTROL MODULE
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• MDR Report Key: 7352411
• Report Number: 9611109-2018-00247
• Device Sequence Number: 784930
• Product Code: DTQ
• UDI-Device Identifier: 04033817900795
• UDI-Public: 010403381790079511171108
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 05/17/2018

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: 28-95-10
• Initial Date Received by Manufacturer: 02/21/2018
• Supplement Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 03/20/2018
• Supplement Report FDA Received Date: 05/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1