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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CINCINNATI SUB-ZERO, LLC. BLANKETROL III SYSTEM, THERMAL REGULATING

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CINCINNATI SUB-ZERO, LLC. BLANKETROL III SYSTEM, THERMAL REGULATING Back to Search Results
Model Number UNKNOWN
Device Problem Temperature Problem (3022)
Patient Problems Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Electrolyte Imbalance (2196)
Event Date 02/15/2017
Event Type  Injury  
Manufacturer Narrative
This incident was not reported to csz by the user and no further information can be found. Csz has made good faith efforts by contacting the fda for more information regarding the incident. The fda responded and is not able to release any more information concerning the name of the user facility, patient information, or the serial number of the device. User stated that previous temperature management systems did not have this issue. It is believed that the user facility understood that the device was programmable (set hourly increments to desired set temp). The biii does not have a programmable feature. Csz examined previous complaint data and product documentation and concluded the user facility most likely did not set the device correctly (temperature/mode); therefore user error was a factor in the incident. No further patient outcome was provided.
 
Event Description
Through csz's post market surveillance, a report was found on fda's maude database concerning the blanketroll iii's (biii) ineffectiveness to maintain temperature. The user facility alleged that the biii achieves the therapeutic temperature but then is ineffective at maintaining the temperature. The user states the biii takes hours to rebound but then states the fast rewarm caused the patient to become hypotensive, tachycardic, unstable, and experienced electrolyte abnormalities beyond the anticipated levels due to constant temperature shifts. The patient was treated iv fluids and medications.
 
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Brand NameBLANKETROL III
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
CINCINNATI SUB-ZERO, LLC.
12011 mosteller road
cincinnati OH 45241
Manufacturer Contact
christina miracle
12011 mosteller road
cincinnati, OH 45241
MDR Report Key6498477
MDR Text Key72961058
Report Number1516825-2017-00008
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
PMA/PMN Number
K101589
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial
Report Date 04/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/20/2017
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/17/2017 Patient Sequence Number: 1
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