MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 GAS BLENDER SYSTEM; GAS CONTROL UNIT, CARDIOPULMONARY BYPASS

Model Number 25-28-67

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.Submitter information are unknown.This information will be provided in a supplemental report if made available.Livanova deutschland manufactures the s5 gas blender system.The incident occurred in the united states.The device was requested back to livanova deutschland for further investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland received a report that a s5 gas blender system suddenly shut off during procedure.There was no report of patient injury.

Manufacturer Narrative

H.10: through follow-up communication livanova deutschland learned the initial reporter information.They have been added to the e.1.Section.

Manufacturer Narrative

Investigation results revealed that the device worked according to its specification.No anomalies have been detected after extensive device testing.

Event Description

See initial.

• Brand Name: S5 GAS BLENDER SYSTEM
• Type of Device: GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 8439233
• MDR Text Key: 139738597
• Report Number: 9611109-2019-00174
• Device Sequence Number: 1
• Product Code: DTX
• UDI-Device Identifier: 04033817901846
• UDI-Public: (01)04033817901846(11)180309
• Combination Product (y/n): N
• PMA/PMN Number: K101046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25-28-67
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1