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

Model Number 48-50-00

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/07/2019

Event Type  malfunction  

Manufacturer Narrative

Livanova (b)(4) manufactures the s5 system.The incident occurred in (b)(4).A livanova representative was able to confirm the reported issue.The technician was able to trace the failure back to a defective board.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 Description

Livanova (b)(4) received a report that a burning smell was noticed during the use of a s5 system.It was further reported that after the burning smell, an error message was displayed on the s5 system.There was no report of patient injury.

Manufacturer Narrative

The board was returned to livanova deutschland for further investigation.During the evaluation the reported issue could be confirmed and reproduced.It was found that a defective component on the bard led to the reported malfunction.

• Brand Name: S5 SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 8439100
• MDR Text Key: 139406952
• Report Number: 9611109-2019-00172
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 04033817900900
• UDI-Public: (01)04033817900900(11)181130
• Combination Product (y/n): N
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48-50-00
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1