MAUDE Adverse Event Report: AUGUSTINE TEMPERATURE MANAGEMENT, LLC HOTDOG PATIENT WARMING; SYSTEM, THERMAL REGULATING

Model Number B105

Device Problems Melted (1385); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/22/2022

Event Type  malfunction  

Event Description

Hotdog air-free conductive pt warming blanket melted while in use during a surgical procedure.No harm to the pt.

• Brand Name: HOTDOG PATIENT WARMING
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): AUGUSTINE TEMPERATURE MANAGEMENT, LLC
• MDR Report Key: 15438397
• MDR Text Key: 300234010
• Report Number: MW5112088
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1