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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 Problems Device Displays Incorrect Message (2591); No Flow (2991)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/20/2017
Event Type  malfunction  
Manufacturer Narrative
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 confirmed. The service engineer performed a routine maintenance. Afterwards, a test run and a tsi check were performed successfully and the device was returned to the customer.
 
Manufacturer Narrative
Patient information was not provided. The s3 gas blender 25-40-00 is not distributed in the usa, but it is similar to s5 gas blender system 25-40-45, which is distributed in the usa (510(k) number: k101046). Livanova (b)(4) manufactures the s3 gas blender system. The incident occurred in (b)(6). This medwatch report is being filed on behalf of livanova (b)(4). A livanova field service representative was dispatched to the facility to investigate. The service representative was unable to reproduce the reported issue. The device has been requested for return to livanova (b)(4) for further evaluation. 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) receive a report that an s3 gas blender system displayed an error message and the flow stopped during a procedure. The user rebooted the device to reestablish flow. There was no report of patient injury.
 
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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. 65thway
arvada, CO 80004
2812287260
MDR Report Key6953496
MDR Text Key250197708
Report Number9611109-2017-00818
Device Sequence Number1
Product Code DTX
Combination Product (y/n)N
Reporter Country CodeNL
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,Followup
Report Date 12/14/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/16/2017
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
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/08/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/29/2004
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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