MAUDE Adverse Event Report: BATTLE CREEK EQUIPMENT THERMOPHORE

Model Number 055

Device Problems Thermal Decomposition of Device (1071); Crack (1135); Smoking (1585); Material Twisted/Bent (2981)

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

Event Type  malfunction  

Event Description

Customer stated, "using and saw smoke, so they unplugged and called us." the product was returned for investigation.The product was approx.10 years old when the incident occurred.Customer stated that the incident lasted a few moments.The customer did not claim any injury.An investigation was done to look into the customers complaint.The investigation found a burn on the cord at the butterfly.The investigator determined that user was misusing the pad.Repeated stress and twisting of the cord caused a break on the cord and led to the burn forming.The pad showed further signs of deterioration and misuse.The cord was twisted.The switch casing was cracked.The pad was stained, bunched, and had bent internal components.This is observed when the pad is folded/ laid on during use.The customer admitted to laying on the pad.The ifu states, "do not sit on, lie on, or crush pad.Avoid sharp folds".The customer was also using the pad after it showed clear signs of deterioration.The ifu states, "carefully examine before each use.Discard unit if it shows signs of deterioration.".

• 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: 8117837
• MDR Text Key: 129337109
• Report Number: 1832415-2018-09840
• 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: 10/31/2018

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/29/2018
• 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