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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 Unexpected Shutdown (4019)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/05/2020
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).A review of the dhr could not identify any deviations or nonconformities relevant to the issue.The involved device was sent to manufacturer for investigation.The reported issue was confirmed and was traced back to a faulty power supply board.
 
Event Description
Livanova (b)(4) received a report of a s5 gas blender system shut-down during procedure.Another device was used to complete the surgery.There was no report of patient injury.
 
Manufacturer Narrative
The power supply was replaced and the issue solved.Subsequent functional verification testing was completed without further issues and the unit was returned to service.
 
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 80309
MDR Report Key10481283
MDR Text Key209384367
Report Number9611109-2020-00501
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 09/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number25-40-45
Was the Report Sent to FDA? No
Date Manufacturer Received09/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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