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U.S. Department of Health and Human Services

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

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CINCINNATI SUB- ZERO PRODUCTS, LLC BLANKETROL SYSTEM, THERMAL REGULATING Back to Search Results
Catalog Number 874
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/02/2016
Event Type  malfunction  
Event Description
Blanketrol ped blanket with leak upon removal from package.   blanket was removed from package and hooked up to machine and when filled with water immediately water sprayed from it.   (water did not reach sterile field or patient. )  machine immediately turned off and blanket replaced.
 
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Brand NameBLANKETROL
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
CINCINNATI SUB- ZERO PRODUCTS, LLC
12011 mosteller rd.
cincinnati OH 45241
MDR Report Key6212375
MDR Text Key63504177
Report Number6212375
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 11/22/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2016
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number874
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/16/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/22/2016
Event Location Hospital
Date Report to Manufacturer11/22/2016
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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