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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 Appropriate Term/Code Not Available (3191)
Patient Problem No Patient Involvement (2645)
Event Date 01/09/2019
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement.Pma/510(k): 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 back 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 displayed an error message during priming.There was no patient involvement.
 
Manufacturer Narrative
H.10.The gas blender system was returned to livanova deutschland for further investigation.During the evaluation the reported issue could not be confirmed or reproduced.The device worked according the specification.As the issue could not be reproduced or confirmed, a root cause was not identified.
 
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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 Key8319710
MDR Text Key135503866
Report Number9611109-2019-00061
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 03/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number25-40-00
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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