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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
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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