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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 01/16/2019
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). Livanova (b)(4) requested the device back for further investigation. 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) received a report that a s3 gas blender system displayed an error message during maintenance. 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
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 89309
GM 89309
Manufacturer Contact
njemile crawley
14401 w. 65th way
arvada, CO 80004
2812287575
MDR Report Key8338244
MDR Text Key137376743
Report Number9611109-2019-00074
Device Sequence Number1
Product Code DTX
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 04/02/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/14/2019
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 Manufacturer01/29/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/04/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/16/2003
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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