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U.S. Department of Health and Human Services

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

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LIVANOVA DEUTSCHLAND GMBH S5 GAS BLENDER SYSTEM GAS CONTROL UNIT, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 25-40-45
Device Problem Gas Output Problem (1266)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/14/2019
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement. Livanova (b)(4) manufactures the s5 gas blender system. The incident occurred in (b)(6). The affected device was requested back to the manufacturer site for a detailed investigation. Results revealed that the reported failure could not be confirmed. The device was found to be properly working. However the power harness cables for air/o2/co2 will be replaced as precaution.
 
Event Description
Livanova (b)(4) received a report that a s5 gas blender system stopped working during procedure and an error code was displayed. 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 GMBH
lindberghstr. 25
munich 80309
GM 80309
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND GMBH
lindberghstr. 25
munich 80309
GM 80309
Manufacturer Contact
enrico greco
14401 w. 65th way
arvada, CO 80004
MDR Report Key9465269
MDR Text Key203001218
Report Number9611109-2019-00962
Device Sequence Number1
Product Code DTX
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K101046
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
Report Date 12/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/13/2019
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? No
Event Location No Information
Date Manufacturer Received11/14/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/14/2008
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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