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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 25-28-67
Device Problem Gas Output Problem (1266)
Patient Problem No Patient Involvement (2645)
Event Date 07/13/2020
Event Type  malfunction  
Manufacturer Narrative
Patient information was not provided.Livanova (b)(4) manufactures the s5 gas blender system.The incident occurred in (b)(6).Unit to be repair.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
 
Event Description
Device checked during preventive maintenance and found that some real values are out of range.
 
Manufacturer Narrative
H.10: livanova requested the claimed unit for a detailed investigation.The reported issue was confirmed.During the calibration an error code associated to a discrepancy between actual and set values was displayed.O2 mass flow controller and o2 valve were replaced and the issue was solved.Subsequent functional verification testing was completed without further issues and the unit was returned to service.Customer information has been added to the dedicated e.1 section.
 
Event Description
See initial report.
 
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Brand Name
S5 GAS BLENDER SYSTEM
Type of Device
GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich
MDR Report Key10394862
MDR Text Key202592720
Report Number9611109-2020-00455
Device Sequence Number1
Product Code DTX
Combination Product (y/n)N
PMA/PMN Number
K101046
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 07/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number25-28-67
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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