MAUDE Adverse Event Report: BATTLE CREEK EQUIPMENT THERMOPHORE

Model Number 155

Device Problems Thermal Decomposition of Device (1071); Fire (1245); Sparking (2595)

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

Event Type  malfunction  

Event Description

Customer stated, " was using the unit and suddenly sparks started shooting out from the on/off switch and the unit caught fire momentarily." customer did not claim injury.Product was returned.The investigator observed a burn mark at the switch and evidence that the user had wrapped the cord.The investigator determined that the wrapping of the cord led to the breaking of the internal components of the switch.The damage from wrapping the cord would lead to the sparking and fire reported.The ifu states, "loop cord loosely when storing.Tight wrapping may damage cord and internal parts.".

• Brand Name: THERMOPHORE
• Type of Device: THERMOPHORE
• Manufacturer (Section D): BATTLE CREEK EQUIPMENT; 702 s reed rd; fremont IN 46737
• Manufacturer Contact: michael green
• MDR Report Key: 9545555
• MDR Text Key: 178317900
• Report Number: 1832415-2019-10976
• 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: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 155
• Device Lot Number: 00155133193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1