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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 25-40-45
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/14/2018
Event Type  malfunction  
Manufacturer Narrative
Patient information was not provided. Livanova (b)(4) manufactures the s5 gas blender system. The incident occurred in (b)(6). The device was requested back to livanova (b)(4) for further investigation and repair. 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 a s5 gas blender system displayed an error message during procedure. There was no report of patient injury.
 
Manufacturer Narrative
The gas blender system was returned to livanova (b)(6) for further investigation and repair. During the evaluation the reported failure could not be reproduced or confirmed. The device was tested intensively without malfunctions. The device was calibrated and subsequent functional verification testing was completed without issues.
 
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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 Key7333859
MDR Text Key102218759
Report Number9611109-2018-00213
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 health professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 09/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number25-40-45
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/20/2018
Is This a Reprocessed and Reused Single-Use Device? No

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