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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 16-02-80
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Patient Involvement (2645)
Event Date 10/30/2017
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement.The heater-cooler 16-02-80 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k052601).Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).The device was requested to livanova (b)(4) for further investigation.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.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 if the heater-cooler system 3t was started, the fuse of the operation room was blown.This issue happened during maintenance.There was no patient involvement.
 
Manufacturer Narrative
The defective device was returned for further investigation.During the investigation the reported failure could be confirmed.As root cause a hole inside the evaporator was identified.Corrective actions are in progress for this issue.
 
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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 80939
GM  80939
MDR Report Key7205057
MDR Text Key98166074
Report Number9611109-2018-00061
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
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 03/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number16-02-80
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/27/2017
Date Manufacturer Received02/23/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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