MAUDE Adverse Event Report: BATTLE CREEK EQUIPMENT THERMOPHORE

Model Number 055

Device Problems Thermal Decomposition of Device (1071); Fire (1245); Nonstandard Device (1420); Sparking (2595)

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

Event Type  malfunction  

Event Description

Customer stated "she was using the pad and she released the trigger to let it cool off.When she pressed the trigger again so the pad would heat back up, the cord sparked and shoot a flame." the product was returned for investigation.The product was approx.4 years 3 months old when the incident occurred.This lot was part of the recall conducted by battle creek equipment.The inspector observed a burn on the strain relief of the cord.This is likely due to excessive flexing of the cord over an extended period to time.The cord was wrapped underneath the switch, which is the probable reason for the break in the cord.Additionally, the cord appeared to have been chewed by a small animal, tag was also chewed.Pad was bunched this is observed when the pad is folded/ laid on during use.Ifu states "do not sit on, lie on, or crush pad.Avoid sharp folds.The switch was taped and the customer used the pad with the taped switch.The pad is operated by constantly pushing the trigger, as soon as the trigger is released the pad stops heating.The customer is misusing the pad by taping the switch.Ifu states "carefully examine before each use.Discard unit if it shows signs of deterioration." customer did not claim any injury 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 IN 46737
• Manufacturer Contact: uday bahal
• MDR Report Key: 7294511
• MDR Text Key: 101034806
• Report Number: 1832415-2017-08757
• 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: 12/27/2017

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?: Yes
• Device Operator: No Information
• Device Model Number: 055
• Device Lot Number: 0553613
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/24/2018
• 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