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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 Name
BLANKETROL III
Type of Device
BLANKET 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 Nurse
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 Health Professional
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age37 YR
Patient Weight88
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