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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S3 GAS BLENDER SYSTEM GAS CONTROL UNIT, CARDIOPULMONARY BYPASS

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LIVANOVA DEUTSCHLAND S3 GAS BLENDER SYSTEM GAS CONTROL UNIT, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 25-40-00
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Patient Involvement (2645)
Event Date 03/13/2018
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement. The gas blender system 25-40-00 is not distributed in the usa, but it is similar to gas blender system 25-40-45, which is distributed in the usa (510(k) number: k052601). Livanova (b)(4) manufactures the s3 gas blender system. The incident occurred in (b)(6). The device was requested to livanova (b)(4) 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 a s3 gas blender system displayed an error message during in-service. There was no patient involvement.
 
Manufacturer Narrative
A livanova field service representative was dispatched to the facility to investigate. The service representative was able to confirm the reported issue. The device was requested for return to livanova (b)(4) for further investigation. However, the customer declined to return the device. No further investigation can be performed. As the device was not returned for investigation, a root cause could not be determined.
 
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Brand NameS3 GAS BLENDER SYSTEM
Type of DeviceGAS CONTROL UNIT, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80939
GM 80939
MDR Report Key7425610
MDR Text Key105519365
Report Number9611109-2018-00881
Device Sequence Number1
Product Code DTX
Combination Product (y/n)N
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 07/19/2018
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 Number25-40-00
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/21/2018
Is This a Reprocessed and Reused Single-Use Device? No

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