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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 08/14/2018
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 gas blender was requested back for further investigation.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 alarmed during set up.The customer was not able to clear the alarm.There was no patient involvement.
 
Manufacturer Narrative
The s5 gas blender system was returned to livanova (b)(4) for further investigation.During the evaluation the reported issue could not be confirmed or reproduced.The device worked according the specification.As the issue could not be reproduced or confirmed, a root cause was not identified.
 
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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 Key7868859
MDR Text Key120105803
Report Number9611109-2018-01222
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
Remedial Action Other
Type of Report Initial,Followup
Report Date 12/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number25-40-45
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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