• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

LIVANOVA DEUTSCHLAND S5 GAS BLENDER SYSTEM GAS CONTROL UNIT, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 25-28-67
Device Problem Gas Leak (2946)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/03/2017
Event Type  malfunction  
Manufacturer Narrative
The device was returned to livanova (b)(4) for investigation and repair. During the investigaton the reported issue could be confirmed. The device showed a physical damage on the front panel, caused by an external force. Furthermore the mass flow controller and the measurement bridges were defective and had to be replaced. It is most likely that the physical damage caused the leak in the co2 system and the defective components which could be identified as root cause of the reported issue. The defective components were replaced to resolve the reported issue. Subsequent functional verification testing was completed without further issues and the unit was returned to the customer.
 
Manufacturer Narrative
Patient information was not provided. (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 has been returned to livanova (b)(4) for evaluation. A review of the dhr did not identify any deviations or non-conformities relevant to the reported 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 the customer suspects that the s5 gas blender system has an internal leak within the co2 system due to high replacement frequency of the co2 cylinders. The device has been removed from service until the leak can be confirmed. There was no report of patient injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key6750215
MDR Text Key264140176
Report Number9611109-2017-00579
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 03/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number25-28-67
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/18/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/10/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-