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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CINCINNATI SUB-ZERO PRODUCTS, INC. HEMOTHERM DUAL RESERVOIR COOLER/HEATER; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
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CINCINNATI SUB-ZERO PRODUCTS, INC. HEMOTHERM DUAL RESERVOIR COOLER/HEATER; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 55552
Device Problem Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/30/2020
Event Type  malfunction  
Event Description
Cincinnati hemotherm dual reservoir cooler/heater was identified as being defective.During precheck of the device, the defect was identified.When turning the unit on, it immediately turns off.Upon review of the device by biomedical engineering, it was determined to be a problem with the power board.A week prior, a different cincinnati hemotherm dual reservoir cooler/heater was identified as having the same problem with the power board.Both devices had new power boards installed on [date redacted] in response to the urgent medical device correction letter received by the company.Defect was identified before reaching the patient.
 
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Brand Name
HEMOTHERM DUAL RESERVOIR COOLER/HEATER
Type of Device
CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
CINCINNATI SUB-ZERO PRODUCTS, INC.
12011 mosteller rd
3rd floor
blue ash OH 45241
MDR Report Key9853330
MDR Text Key184079626
Report Number9853330
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number55552
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/31/2020
Device Age3 YR
Date Report to Manufacturer03/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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