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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 25-40-40
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Patient Involvement (2645)
Event Date 05/07/2019
Event Type  malfunction  
Manufacturer Narrative
Patient information was not provided.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 bad (b)(6).The affected part has been requested back to the manufacturer site for a detailed investigation.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.
 
Event Description
Livanova (b)(4) received a report that a s3 gas blender system displayed an error message during priming.There was no patient involvement.
 
Manufacturer Narrative
The reported error could not be duplicated during the investigation.
 
Manufacturer Narrative
H.10: through follow up communication livanova learned that the issue was confirmed afterwards and the customer rejected the repair.
 
Event Description
See initial report.
 
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Brand Name
S3 GAS BLENDER SYSTEM
Type of Device
GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich
MDR Report Key8673370
MDR Text Key147618928
Report Number9611109-2019-00424
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
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 Received06/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number25-40-40
Was the Report Sent to FDA? No
Date Manufacturer Received03/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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