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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S3 GAS BLENDER SYSTEM; GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
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LIVANOVA DEUTSCHLAND S3 GAS BLENDER SYSTEM; GAS CONTROL UNIT, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 25-40-47
Device Problem Gas Output Problem (1266)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/28/2020
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement.Livanova deutschland manufactures the gas blender system.The incident occurred in utrecht, netherlands.A new gas blender was provided to the customer.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
 
Event Description
Livanova deutschland received a report that a gas blender system gave an error code associated to the a/d converter at the end of the procedure.There was no report of patient injury.
 
Manufacturer Narrative
Has been updated with the correct model number.Has been updated with the manufacturing date.The device was returned to the manufacturer site for repair.The reported issue was confirmed and another error code appeared.Due to the old device model, spare parts for replacement are no longer available thus, the device will be labeled "not for clinical use" and returned to the customer.
 
Event Description
See initial report.
 
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Brand Name
S3 GAS BLENDER SYSTEM
Type of Device
GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich
MDR Report Key10903700
MDR Text Key218249649
Report Number9611109-2020-00655
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 11/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number25-40-47
Was the Report Sent to FDA? No
Date Manufacturer Received11/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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