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

Model Number	28-95-85
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Livanova (b)(4) manufactures the s5 control panel mrp.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).A serial readout of the pump has been provided to livanova (b)(4) for further evaluation.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The investigation is on-going.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 control panel mrp lost power during a procedure.The device was restarted but it lost power again.The user decided to continue the procedure without the pump, which was being used as a suction pump.There was no report of patient injury.
Additional Manufacturer Narrative
Livanova (b)(4) manufactures the s5 control panel mrp.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).During evaluation of the readout, the reported issue was confirmed.Many cpu clock deviation errors were identified.It was recommended to replace the pcb hkr 0325 (90-305-620).Livanova (b)(6) decided to return the complete s5 control panel mrp 85 to livanova (b)(4) for further investigation, where the reported issue was confirmed again and a defective pcb hkr 0325 was identified as the cause.The voltage regulator was short-circuited due to contamination (soldering flux residue).The device was repaired and subsequent functional testing and technical safety inspection were successfully completed.The device was returned to the customer.Corrective actions have been implemented for this type of issue.

• Brand Name: S5 CONTROL PANEL MRP
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• MDR Report Key: 6522139
• Report Number: 9611109-2017-00314
• Device Sequence Number: 734501
• Product Code: DWB
• UDI-Device Identifier: 04033817900825
• UDI-Public: 010403381790082511151110
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/25/2017

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: 28-95-85
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/03/2017
• Supplement Date Received by Manufacturer: 08/31/2017
• Initial Report FDA Received Date: 04/26/2017
• Supplement Report FDA Received Date: 09/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1