MAUDE Adverse Event Report: BATTLE CREEK EQUIPMENT THERMOPHORE

Model Number 055

Device Problems Break (1069); Thermal Decomposition of Device (1071)

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

Event Type  malfunction  

Event Description

Customer stated "pad was laying on his shoulder.Wife smelled something burning, he saw sparks for a couple of seconds.Then he unplugged the pad.Burnt a hole in the sheet and mattress pad, and mattress.Took the pad outside and put baking soda and water on it." the product was returned for investigation.The product was approx.8 years and 1 months old when the incident occurred.An investigation was done into the customers complaint.The investigator noticed that the pad cover had a burn and also observed a burn at the butterfly of the cord.This is likely due to excessive flexing of the cord over an extended period to time.Additionally, cord was looped by the strain relief.Pad was bunched, had broken lead, discolored thermostat, these signs are observed when the pad is folded/ laid on during use.Ifu states "do not sit on, lie on, or crush pad.Avoid sharp folds." 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: 7282370
• MDR Text Key: 100660308
• Report Number: 1832415-2017-08695
• 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: 12/12/2017

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: 092870
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/20/2018
• 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