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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CINCINNATI SUB-ZERO PRODUCTS, INC. BLANKETROL® LLL SYSTEM, THERMAL REGULATING

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CINCINNATI SUB-ZERO PRODUCTS, INC. BLANKETROL® LLL SYSTEM, THERMAL REGULATING Back to Search Results
Model Number 233
Device Problem Device Alarm System (1012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/17/2020
Event Type  malfunction  
Event Description
Patient's esophogeal temperature was 32. 2. The patient's entered temperature in the blanketrol iii thermal regulating system was 33. 5. Device did not alarm once temperature was outside of the desired range. The esophageal temperature probe was replaced.
 
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Brand NameBLANKETROL® LLL
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
CINCINNATI SUB-ZERO PRODUCTS, INC.
12011 mosteller rd 3rd floor
cincinnati OH 45241
MDR Report Key10091471
MDR Text Key192160221
Report Number10091471
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 Risk Manager
Type of Report Initial
Report Date 05/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number233
Device Catalogue Number86107
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/21/2020
Event Location Hospital
Date Report to Manufacturer05/27/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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