MAUDE Adverse Event Report: BATTLE CREEK EQUIPMENT THERMOPHORE

Model Number 055

Device Problems Thermal Decomposition of Device (1071); Fire (1245); Loose or Intermittent Connection (1371); Device Emits Odor (1425); Smoking (1585)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Customer stated "i was laying there and i was laying on the pad, it went pop and i smell something and the pad was smoking and caught on fire.Turn the pad and my cover black.Read the whole instruction and said it does not say i can't lay on it say sit." product was returned for investigation.An investigation was done into the customers complaint, and the inspector found that the cord had burned right by the pad.This was caused by the cord having a cut by the pad likely due to excessive flexing of the cord over an extended period to time.Ifu states "loop cord loosely when storing.Tight wrapping may damage cord and internal parts." customer was also misusing the pad as customer stated that they lay on the pad.Ifu states "do not sit on, lie on, or crush pad.Avoid sharp folds." customer did not claim any injury the product was approx.6 years old when the incident occurred.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: 7233362
• MDR Text Key: 98867545
• Report Number: 1832415-2017-05685
• 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: 05/04/2016

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: 100530
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2018
• 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