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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEMOTHERM 400 CE; CARDIOPULMONARY BYPASS TEMPERATURE CONTROLLER
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HEMOTHERM 400 CE; CARDIOPULMONARY BYPASS TEMPERATURE CONTROLLER Back to Search Results
Model Number 400CE
Device Problem Device Issue (2379)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/20/2018
Event Type  malfunction  
Manufacturer Narrative
Csz received a complaint stating the device went down during a procedure.The device was switched out and the procedure finished successfully.The user facility investigated and found a fuse blew on the power board.The facility replaced the power board and the device functions as designed.No patient harm or injury occurred.
 
Event Description
Csz received a complaint stating the device went down during a procedure.The device was switched out and the procedure finished successfully.No patient harm or injury occurred.This report was filed in our complaint handling system as complaint #(b)(4).
 
Manufacturer Narrative
Service evaluation confirmed the f6 fuse was blown.Discovered the fuse clips were spread and not making appropriate contact with fuse.
 
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Brand Name
HEMOTHERM 400 CE
Type of Device
CARDIOPULMONARY BYPASS TEMPERATURE CONTROLLER
MDR Report Key7433173
MDR Text Key106022189
Report Number1516825-2018-00003
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
PMA/PMN Number
K122813
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 04/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number400CE
Device Catalogue Number86022
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/04/2018
Was the Report Sent to FDA? No
Date Manufacturer Received03/20/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/15/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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