MAUDE Adverse Event Report: BATTLE CREEK EQUIPMENT THERMOPHORE

Model Number 055

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Customer stated "pad burnt hole in pad and burnt the floor.He used the pad on the floor to warm his feet." product was returned for investigation.An investigation was done into the customers complaint, and the inspector found that the product had an e-stat failure.The pad was produced in 1999, the product was approx.17 years old when the incident occurred.Also the heater wire and metal clips were both imprinted on the pad, which is typically only seen in product that had been folded or laid on while being in use.Based on the bce review of feedbacks, bce did not observe a similar issue within the lot.

• Brand Name: THERMOPHORE
• Type of Device: THERMOPHORE
• Manufacturer (Section D): BATTLE CREEK EQUIPMENT; 702 s reed rd; fremont 46737
• Manufacturer Contact: uday bahal
• MDR Report Key: 6927708
• MDR Text Key: 89856272
• Report Number: 1832415-2017-07798
• 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: 04/26/2017

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?: No
• Device Operator: No Information
• Device Model Number: 055
• Device Lot Number: 992850
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/07/2017
• 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