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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 25-40-46
Device Problem No Flow (2991)
Patient Problem No Patient Involvement (2645)
Event Date 09/20/2017
Event Type  malfunction  
Manufacturer Narrative
Livanova (b)(4) manufactures the s5 gas blender system. The event 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 deviation in the o2 flow which was caused by a defective mass flow controller. After the replacement of the defective part, the device was re-calibrated and subsequent tests were performed successfully. A review of the dhr could not identify any deviations or nonconformities relevant to the issue.
 
Manufacturer Narrative
There was no patient involvement. Livanova (b)(4) manufactures the s5 gas blender system. The event occurred in (b)(6). This medwatch report is being filed on behalf of livanova (b)(4). The device was returned to livanova (b)(6) where the issue was confirmed. The unit has been returned to livanova (b)(4) 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 relevant to the reported event is received, it will be provided in a supplemental report.
 
Event Description
Livanova (b)(4) received a report that an s5 gas blender system had no oxygen flow. 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 Key6956622
MDR Text Key249469327
Report Number9611109-2017-00823
Device Sequence Number1
Product Code DTX
Combination Product (y/n)N
Reporter Country CodeUK
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 01/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number25-40-46
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/04/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/25/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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