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

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.

• Brand Name: HOT DOG PATIENT WARMING SYSTEM MULTIFUNCTION CONTROLLER
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): AUGUSTINE TEMPERATURE MANAGEMENT LLC; 7656 w. 78th st; minneapolis MN 55439
• MDR Report Key: 13051708
• MDR Text Key: 282575495
• Report Number: 13051708
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: WC52
• Device Catalogue Number: WC52
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/13/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30295 DA
• Patient Sex: Male