MAUDE Adverse Event Report: BATTLE CREEK EQUIPMENT THERMOPHORE

Model Number 058

Device Problems Thermal Decomposition of Device (1071); Fire (1245); Smoking (1585); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

User stated, the user woke up to a smell of smoke and fire, burn holes in the bedwarmer.The user did not claim any injury.The product was returned for investigation.An investigation was done to look into the users complaint.The investigator observed the presence of burn holes in the product.The investigator found that the position of the holes indicates that the bedwarmer was folded during use.The misuse (folding the bedwarmer) caused the creation of hotspot which led to the burn holes in the bedwarmer.Ifu says, "keep the bedwarmer¿ smooth and flat in use." the investigator confirmed that correct heater wire was used in the bedwarmer.Also, the heater wire length and pattern were correct.

• Brand Name: THERMOPHORE
• Type of Device: THERMOPHORE
• Manufacturer (Section D): BATTLE CREEK EQUIPMENT; 702 s reed rd; fremont IN 46737
• Manufacturer Contact: uday bahal
• MDR Report Key: 8689145
• MDR Text Key: 147889069
• Report Number: 1832415-2019-10506
• Device Sequence Number: 1
• Product Code: IRT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 058
• Device Lot Number: 00058003195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1