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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CINCINNATI SUB ZERO / GENTHERM MEDICAL, LLC . CINCINNATI SUB ZERO HEATER COOLER CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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CINCINNATI SUB ZERO / GENTHERM MEDICAL, LLC . CINCINNATI SUB ZERO HEATER COOLER CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Date 10/14/2020
Event Type  Malfunction  
Event Description

Heater cooler cultured as part of heater and cooler culturing. Fda safety report id # (b)(4).

 
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Brand NameCINCINNATI SUB ZERO HEATER COOLER
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
CINCINNATI SUB ZERO / GENTHERM MEDICAL, LLC .
cincinnati OH 45241
MDR Report Key11776729
MDR Text Key249445165
Report NumberMW5101168
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 05/03/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/04/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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