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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 Problem Infusion or Flow Problem (2964)
Patient Problem No Patient Involvement (2645)
Event Date 03/20/2018
Event Type  malfunction  
Manufacturer Narrative
Livanova (b)(4) manufactures the s5 gas blender system. The incident occurred in (b)(6). A livanova field service representative was dispatched to the facility to investigate. The service representative was not able to confirm or reproduce the reported issue. Subsequent functional verification testing was completed without issues and the unit was returned to service. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report. Evaluated on site by livanova rep.
 
Event Description
Livanova (b)(4) received a report that a s5 gas blender system turned to zero sweep and alarmed intermittent during procedure. There was no report of patient injury.
 
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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 Key7436029
MDR Text Key105694088
Report Number9611109-2018-00894
Device Sequence Number1
Product Code DTX
Combination Product (y/n)N
Reporter Country CodeUS
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
Report Date 04/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/17/2018
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? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/20/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/15/2010
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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