MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH EVO PANEL - S5 ACCESSORIES; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	28-95-70
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H10: livanova deutschland manufactures the electrical venous occluder (evo).The incident occurred in japan.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova deutschland received a report that, during a procedure, the control knob of the evo panel suddenly came off.It was attached it again, it is spinning inside and cannot be used.There is no report of any patient injury.
Additional Manufacturer Narrative
Regarding this complaint, the customer was mistaken and the repair order was cancelled.Based on the information received, since the repair order was canceled by the customer due to its mistake, there was no alleged malfunction of the device.The event has been reassessed as not reportable.Livanova will keep monitoring the market.H3 other text : request cancelled.
Event or Problem Description
See intial report.

• Brand Name: EVO PANEL - S5 ACCESSORIES
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 17621985
• Report Number: 9611109-2023-00396
• Device Sequence Number: 17988462
• Product Code: DTQ
• UDI-Device Identifier: 04033817900801
• UDI-Public: (01)04033817900801(11)181122
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K210130
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2024

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: 28-95-70
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2023
• Supplement Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2018
• 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