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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 Appropriate Term/Code Not Available (3191)
Patient Problem No Patient Involvement (2645)
Event Date 06/17/2019
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 part was returned to livanova (b)(4) for a detailed investigation. The investigator could reproduce the reported issue. As the device showed the complained malfunction only once during investigation, the problem could not be traced to a specific component. A review of the dhr could not identify any deviations or nonconformities relevant to the 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 s5 gas blender system displayed an error message concerning a deviation from the set and the actual gas flow, which was proven to be flawless. This was observed during maintenance. 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
barbara galasso
14401 w. 65th way
arvada, CO 80004
MDR Report Key8863719
MDR Text Key174889583
Report Number9611109-2019-00602
Device Sequence Number1
Product Code DTX
Combination Product (y/n)N
Reporter Country CodeSZ
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 08/06/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/06/2019
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? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/09/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/29/2018
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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