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

Model Number	48-30-00
Medical Device Problem Code	Electrical Shorting (2926)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Livanova deutschland manufactures the s5 system.The incident occurred in (b)(6).Through follow-up communication livanova learned that the s5 was used with cp5 connected during an ecmo case.The s5 switched to battery when the ac mains tripped and then shut down when the batteries ran out (deep discharge).To solve the ac tripping issue, the distributor engineer replaced the switching power supply and batteries of the s5 system.The defective switching power supply is the most likely root cause of the reported power tripping.In addition, it was reported that following to battery discharge the perfusionist hand-cranked the cp5 emergency drive (model number 60-01-35; serial number (b)(4)) for 1 hour until the cable of the emergency drive system broke.The cable of the emergency driver will be repaired at the manufacturer site.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova received report that the ac power supply of the operating room tripped and would trip every time when the s5-cp5 machine was plugged in.There was no patient affected.
Additional Manufacturer Narrative
H.10.As anticipated in the initial report, the defective switching power supply is the most likely root cause of the reported power tripping.In addition, through follow-up communication livanova learned that when the emergency drive system broke, the customer used another ecmo console to continue the procedure.It cannot be ruled out that the intensive use during the procedure could have contributed to the mechanical damage.
Event or Problem Description
See initial report.

• Brand Name: S5 SYSTEM
• 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 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 15215668
• Report Number: 9611109-2022-00420
• Device Sequence Number: 20114031
• Product Code: DTQ
• UDI-Device Identifier: 04033817900887
• UDI-Public: (01)04033817900887(11)200806
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 08/09/2022

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: 48-30-00
• 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: 07/18/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 08/12/2022
• Supplement Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2020
• 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