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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
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LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 16-02-85
Device Problems Insufficient Heating (1287); Noise, Audible (3273)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/18/2018
Event Type  malfunction  
Manufacturer Narrative
Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(4).If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.
 
Event Description
Livanova (b)(4) received a report that a heater-cooler system 3t is making a bubbling noise and it seems that it needs longer to warm up during the procedure.There was no report of patient injury.
 
Manufacturer Narrative
The defective heater-cooler system 3t was returned for further investigation.During the evaluation the reported issue could not be reproduced or confirmed.The device worked according the specification.As the issue could not be reproduced or confirmed, a root cause was not identified.
 
Event Description
See initial.
 
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Brand Name
HEATER-COOLER SYSTEM 3T
Type of Device
CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich
MDR Report Key7521513
MDR Text Key108733529
Report Number9611109-2018-00968
Device Sequence Number1
Product Code DWC
UDI-Device Identifier04033817900528
UDI-Public010403381790052811171130
Combination Product (y/n)N
PMA/PMN Number
K052601
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 01/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number16-02-85
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/07/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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