MAUDE Adverse Event Report: BATTLE CREEK EQUIPMENT THERMOPHORE

Model Number 056

Device Problems Thermal Decomposition of Device (1071); Fire (1245); Improper or Incorrect Procedure or Method (2017); Sparking (2595)

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

Event Type  malfunction  

Event Description

Customer stated "she was laying in bed on her back on the pad.She was holding the switch in her right hand and resting her hand on her stomach.She pushed down the lever on the switch and sparks shot out of the switch and then flames shot out " product was returned for investigation.The product was approx.(b)(6) years old when the incident occurred.Upon further investigation into the customers complaint, the inspector found that the cord had a small burn on it, near the strain relief.This is likely due to excessive flexing of the cord over an extended period to time.Based on the bce review of feedbacks, bce did not observe a similar issue within the lot.Consumer was also misusing the pad because she stated that she was laying in bed on her back in the pad.Ifu states "do not sit on, lie on, or crush pad.Avoid sharp folds.".

• 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: 7193896
• MDR Text Key: 97637645
• Report Number: 1832415-2017-08074
• 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: 07/07/2017

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: 056
• Device Lot Number: 0021691
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/16/2018
• 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