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

Model Number	28-98-80
Medical Device Problem Codes	Failure to Power Up (1476); Electrical Power Problem (2925); Electrical Shorting (2926)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Sorin group (b)(4) manufactures the s5 ups module.The incident occurred in ((b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group received a report that a bad smell came from the sorin s5 system when it was switched on without ac power during a demonstration.The s5 system was switched off and back on using ac power and the unit displayed multiple error messages.There was no patient involvement.The distributor service engineer evaluated the e/p pack of the s5 system and identified a burnt component on the pcb board of the ups module.The service engineer replaced the defective device.The unit was returned to munich for further investigation.During functional testing, the reported issue was reproduced.Two components on the pcb of the returned ups module were identified to be defective (short-circuited and burnt).The root cause for the failure could not be determined.The returned device was scrapped as a precaution.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.No trend was identified for this type of issue.Sorin group (b)(4) will continue to monitor the market for trends related to this type of issue.The complained unit was replaced on-site to resolve the issue.No further action is necessary at this time.
Event or Problem Description
Sorin group (b)(4) received a report that a bad smell came from the sorin s5 system when it was switched on without ac power during a demonstration.The s5 system was switched off and back on using ac power and the unit displayed multiple error messages.There was no patient involvement.

• Brand Name: S5 UPS MODULE
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• MDR Report Key: 6040500
• Report Number: 9611109-2016-00667
• Device Sequence Number: 1837934
• Product Code: DTQ
• UDI-Device Identifier: 04033817901259
• UDI-Public: 010403381790125911160215
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Report Date (Section B): 09/20/2016

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2016
• Initial Report FDA Received Date: 10/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1