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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 25-40-47
Device Problem Inaccurate Flow Rate (1249)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/18/2018
Event Type  malfunction  
Manufacturer Narrative
Livanova (b)(4) manufactures the s5 gas blender system. The incident occurred in (b)(6). A livanova field service representative was dispatched to the facility to investigate. The service representative was able to replicate the reported issue and confirmed that the error message was displayed due to the unstable flow. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. 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 on a s5 gas blender system the flow was not stable and displayed an error message during procedure. There was no report of patient injury.
 
Manufacturer Narrative
Two errors have been displayed during investigation at the manufacturer site confirming a deviation between the set and the actual values. The co2 mass flow controller,co2 flow sensor and the eprom have been replaced and the issue solved. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
 
Event Description
See initial.
 
Event Description
See initial.
 
Manufacturer Narrative
As root cause of the issue a defective co2 monitoring sensor has been identified. In order to solve the issue, the co2 sensor has been replaced. The unit has been checked without showing further deviations.
 
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Brand NameS5 GAS BLENDER SYSTEM
Type of DeviceGAS CONTROL UNIT, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich
MDR Report Key7973259
MDR Text Key123951629
Report Number9611109-2018-01294
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,Followup
Report Date 07/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number25-40-47
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/14/2019
Is This a Reprocessed and Reused Single-Use Device? No

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