MAUDE Adverse Event Report: BATTLE CREEK EQUIPMENT THERMOPHORE

Model Number 055

Device Problems Thermal Decomposition of Device (1071); 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 pad had started a fire on the couch." the product was returned for investigation.The customer did not claim any injury.The product was approx.24 years old when the incident occurred.An investigation was done to look into the customers complaint.The investigator determined the customer had misused the pad as it was folded and laid on during use.The ifu states, "do not sit on, lie on, or crush pad.Avoid sharp folds".It was observed that the heater wire pattern had been compromised due to misuse over time.The misuse of the pad along with the compromised heater wire layout on the pad probably lead to creation of hotspots.User said that after using the pad, user left the pad on the couch, and when user returned 10 minutes later pad was smoking and burning the couch.The pad has a deadman's switch, when the trigger is not pressed, pad does not produce any heat.The investigator observed that the switch was working fine.When the user left, the pad had hotspots due to misuse which when left for 10 minutes on the couch probably lead to smoking and burning of the couch user described.

• 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: 8672535
• MDR Text Key: 147449988
• Report Number: 1832415-2019-10484
• 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: 05/06/2019

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: 055
• Device Lot Number: 951020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/05/2019
• 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