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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CINCINNATI BLANKETROL III BLANKET WARMER/COOLER

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CINCINNATI BLANKETROL III BLANKET WARMER/COOLER Back to Search Results
Device Problems Device Operates Differently Than Expected (2913); Temperature Problem (3022)
Patient Problems Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Electrolyte Imbalance (2196); Alteration In Body Temperature (2682)
Event Date 02/03/2017
Event Type  Injury  
Event Description
The hospital currently uses the cincinnati sub zero blanketrol iii for therapeutic temperature management after cardiac arrest and return of spontaneous circulation. The blanketrol iii can achieve this temperature but is ineffective at maintaining this temperature. The blanketrol iii then takes hours to rebound. The subsequent fast rewarm caused this pt to become hypotensive, tachycardic, unstable, and to experience electrolyte abnormalities beyond the anticipated levels due to constant temperature shifts. The pt was treated with iv fluids and medications. These problems did not occur with previous temperature management blanket system. Blanketrols were taken out of service and are being evaluated by the biomedical department.
 
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Brand NameBLANKETROL III
Type of DeviceBLANKET WARMER/COOLER
Manufacturer (Section D)
CINCINNATI
MDR Report Key6339124
MDR Text Key67822824
Report NumberMW5067934
Device Sequence Number1
Product Code DWJ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 02/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
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

Patient Treatment Data
Date Received: 02/15/2017 Patient Sequence Number: 1
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