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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 05/18/2017
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 returned to livanova (b)(4) for further investigation. The problem could not be reproduced. During investigation no error code was displayed. The service engineer performed a routine maintenance and a recalibration. Subsequent functional verification testing was completed without further issues and the unit was returned to the customer. A review of the dhr could not identify any deviations or nonconformities relevant to the issue. Initially, this event was determined to be non-reportable, as the device is not distributed in the usa. However, upon further review, it has been concluded that the device is similar to one that is distributed in the usa. A retrospective review of all complaints for this type of device was performed and this event has been reevaluated as reportable based on the new decision.
 
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.
 
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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
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr 25
munich 80939
GM 80939
Manufacturer Contact
joan ceasar
14401 w. 65th way
arvada, CO 80004
2812287260
MDR Report Key7233351
MDR Text Key98758159
Report Number9611109-2018-00080
Device Sequence Number1
Product Code DTX
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 02/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/01/2018
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? Device Returned to Manufacturer
Date Returned to Manufacturer05/29/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/11/1999
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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