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

Model Number	28-98-80
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that a s5 ups module emitted smoke from its component following its installation into a s5 pro system and the turning on of the unit.There was no patient involvement.
Additional Manufacturer Narrative
There was no patient involvement.Livanova deutschland manufactures the s5 ups module.The incident occurred in (b)(6), indonesia.Following the reported issue, ups module was checked by a livanova field service representative and it was noted that there were components that were burnt.Moreover, power supply module and also battery board were checked: all worked fine, without burnt components.Livanova initiated an investigation.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H10: through follow-up communication with livanova technician, it was learned that a further inspection and investigation on the unit returned was carried out.It was found that the wiring harness of the e/p pack has been disconnected and is not more in original production condition; cables were unscrewed from the hus board and screwed again, and marked with a not original tape.Also ups module has been inspected and found marks of burning components inside.E/p pack was tested with replacement ups module without further issues.All worked as expected.Based on this further investigation, it cannot be ruled out that the reported issue could be due to plug / unplug operation while the e/p pack was working.
Additional Manufacturer Narrative
H10: correct model and serial number of the involved s5 ups module have been added to section d of this report.The complete e/p pack, with power supply module, the dc/dc module and the ups module were returned to livanova deutschland for a detailed investigation.The e/p pack was opened: the cables were found to be unscrewed from the hus circuit board and marked so that they can be screwed back into the correct position on the circuit board.No deviations were detected in the e/p pack and in the batteries and the wires were not replaced.The failure was confirmed and traced back to the ups module.Complaints database analysis revealed that no similar event on this device occurred since its installation in 2022.Based on the above investigation results and considering that no deviations were detected in the e/p pack during unit inspection at livanova, it cannot be ruled out that the most likely root cause of the reported issue can be traced back to faulty ups module.
Event or Problem Description
See initial report.

• Brand Name: S5 UPS MODULE
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 16520055
• Report Number: 9611109-2023-00104
• Device Sequence Number: 6458725
• Product Code: DTQ
• UDI-Device Identifier: 04033817901259
• UDI-Public: (01)04033817901259(11)221020
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K071318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/10/2023

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2022
• Supplement Date Received by Manufacturer: 04/20/2023; 06/07/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 05/16/2023; 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown