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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 Device Displays Incorrect Message (2591)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement. Event date has not been provided. This information will be provided in a supplemental report if made available. (b)(4) manufactures the s5 gas blender system. The incident occurred in (b)(6). This medwatch report is being filed on behalf of livanova (b)(4). The device was returned to livanova (b)(4) for repair. The technician was not able to confirm the reported issue. The device was calibrated and subsequent functional verification testing was completed without issues. 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 s5 gas blender system displayed an error message and the s5 system displayed an "external device defective" message 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
joan ceasar
14401 w. 65th way
arvada, CO 80004
2812287260
MDR Report Key6757142
MDR Text Key81506215
Report Number9611109-2017-00589
Device Sequence Number1
Product Code DTX
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K101046
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 08/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/01/2017
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 Manufacturer07/04/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/04/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/26/2015
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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