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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 GAS BLENDER SYSTEM GAS CONTROL UNIT, CARDIOPULMONARY BYPASS

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LIVANOVA DEUTSCHLAND S5 GAS BLENDER SYSTEM GAS CONTROL UNIT, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 25-40-45
Device Problems Device Displays Incorrect Message (2591); Device Handling Problem (3265)
Patient Problem No Patient Involvement (2645)
Event Date 07/27/2017
Event Type  malfunction  
Manufacturer Narrative
Livanova (b)(4) manufactures the s5 gas blender system. The incident occurred in (b)(6). The device was sent to livanova (b)(4) for investigation. The service engineer inspected the device and was able to confirm the reported issue. During inspection, the calibration showed a deviaition in the o2 flow and the temperature sensor was identified as not working properly. The measurement bridge, the mass flow controller and the front panel required replacement. After the replacement of the parts, a recalibration, and a functional check were performed with no further issue. The device was returned to service.
 
Manufacturer Narrative
There was no patient involvement. Initial contact telephone number: (b)(6). Livanova (b)(4) manufactures the s5 gas blender system. The incident occurred in bad (b)64). This medwatch report is being filed on behalf of livanova (b)(4). A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. The device has been returned to livanova (b)(4) for evaluation. 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 s5 gas blender system displayed an error message could not be adjusted during priming. There was no patient involvement.
 
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Brand NameS5 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 Key6822567
MDR Text Key251108479
Report Number9611109-2017-00667
Device Sequence Number1
Product Code DTX
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K101046
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 Received08/25/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number25-40-45
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/01/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/09/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/09/2016
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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