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U.S. Department of Health and Human Services

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

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LIVANOVA DEUTSCHLAND S5 GAS BLENDER SYSTEM GAS CONTROL UNIT, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 25-28-67
Device Problem Inaccurate Flow Rate (1249)
Patient Problem No Patient Involvement (2645)
Event Date 11/13/2017
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement. Livanova (b)(4) manufactures the s5 gas blender system. The incident occurred in (b)(6). The defective gas blender was requested 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 (b)(4) received a report that during the maintenance the measured flow of a s5 gas blender system was not correct. There was no patient involvement.
 
Manufacturer Narrative
The gas blender system was returned to livanova (b)(4) for further investigation. During evaluation of the returned device, the reported issue could not be reproduced. The device worked according the specification. Functional verification testing and a routine calibration were completed without issues and the unit was returned to the customer. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.
 
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Brand NameS5 GAS BLENDER SYSTEM
Type of DeviceGAS CONTROL UNIT, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80939
GM 80939
MDR Report Key7426306
MDR Text Key105694362
Report Number9611109-2018-00889
Device Sequence Number1
Product Code DTX
Combination Product (y/n)N
PMA/PMN Number
K101046
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Remedial Action Other
Type of Report Initial,Followup
Report Date 07/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number25-28-67
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/02/2018
Is This a Reprocessed and Reused Single-Use Device? No

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