Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 12/05/2017
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).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 a heater-cooler system 3t shuts down the mains if the device is turned on during setup.There was no patient involvement.
 
Manufacturer Narrative
The defective heater-cooler system 3t was returned for further investigation.During the investigation the reported failure could be confirmed.As root cause a hole inside the evaporator was identified which was caused by corrosion.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7157865
MDR Text Key96239507
Report Number9611109-2018-00007
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 04/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
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? Yes
Initial Date Manufacturer Received 12/06/2017
Initial Date FDA Received01/02/2018
Supplement Dates Manufacturer Received03/12/2018
Supplement Dates FDA Received04/05/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-