• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CINCINNATI SUB-ZERO PRODUCTS, LLC HEMOTHERM 400CE CARDIOPULMONARY BYPASS TEMPERATURE CONTROLLER

  • 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
 

CINCINNATI SUB-ZERO PRODUCTS, LLC HEMOTHERM 400CE CARDIOPULMONARY BYPASS TEMPERATURE CONTROLLER Back to Search Results
Model Number 400CE
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/14/2018
Event Type  Malfunction  
Manufacturer Narrative

Csz received complaint (b)(4) indicating the device displayed the ee02 error code during a procedure. The ee02 error code informs the user of a heat thermistor discrepancy. The unit was swapped out and the procedure was completed. No patient harm or injury occurred.

 
Event Description

Csz received a complaint that the hemotherm device displayed the ee02 error code during a procedure.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHEMOTHERM 400CE
Type of DeviceCARDIOPULMONARY BYPASS TEMPERATURE CONTROLLER
Manufacturer (Section D)
CINCINNATI SUB-ZERO PRODUCTS, LLC
12011 mosteller road
cincinnati OH 45241
Manufacturer Contact
christina miracle
12011 mosteller road
cincinnati, OH 45241
5133265295
MDR Report Key7866627
MDR Text Key120119880
Report Number1516825-2018-00014
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK122813
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial
Report Date 09/11/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/11/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number400CE
Device Catalogue Number400CE
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/14/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured06/21/2018
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-