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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AUGUSTINE TEMPERATURE MANAGEMENT LLC HOT DOG PATIENT WARMING SYSTEM MULTIFUNCTION CONTROLLER SYSTEM, THERMAL REGULATING

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AUGUSTINE TEMPERATURE MANAGEMENT LLC HOT DOG PATIENT WARMING SYSTEM MULTIFUNCTION CONTROLLER SYSTEM, THERMAL REGULATING Back to Search Results
Model Number WC52
Device Problem Insufficient Information (3190)
Patient Problem Superficial (First Degree) Burn (2685)
Event Date 11/16/2021
Event Type  malfunction  
Event Description
During this surgery, clinical staff received a call from the post-anesthesia care unit about a "welt" on the patients left knee. Doctor was going to check on the previous patients knee after this surgery was completed. Doctor determined it was a burn on the left knee on the previous patient. Clinical staff checked the hotdog patient warming system on the current patient and it was very hot to the touch. Clinical staff took it off and saw the patient's knees looked to be burned as well. The reading on the hotdog device was 41 degrees which is normal. The machine and the blanket were both good on dates and were not expired. A blanket was placed on both patients creating a barrier between the hotdog blanket and patients skin. The machine and blanket were both removed from the room and sent down to be looked at.
 
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Brand NameHOT DOG PATIENT WARMING SYSTEM MULTIFUNCTION CONTROLLER
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
AUGUSTINE TEMPERATURE MANAGEMENT LLC
7656 w. 78th st
minneapolis MN 55439
MDR Report Key13051708
MDR Text Key282575495
Report Number13051708
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 Other Health Care Professional
Type of Report Initial
Report Date 12/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberWC52
Device Catalogue NumberWC52
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/13/2021
Event Location Hospital
Date Report to Manufacturer12/21/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/21/2021 Patient Sequence Number: 1
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