MAUDE Adverse Event Report: BATTLE CREEK EQUIPMENT THERMOPHORE

Model Number 155

Device Problems Break (1069); Thermal Decomposition of Device (1071); Fire (1245); Improper or Incorrect Procedure or Method (2017)

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

Event Type  malfunction  

Event Description

Customer stated, "looked down and saw crispy black and red circle on the pad and the circle was getting bigger.He unplugged the pad and ran to the sink and wet the pad down to stop the fire and burn.The product was returned for investigation.The customer did not claim any injury.An investigation was done to look into the customers complaint.The investigator found a burn on the pad.The heater wire broke at the harness.The exposed wire likely arced and caused the burn.The investigator also determined that the customer was misusing the pad by folding and laying on the pad during use.The bottom of the pad was bunched as if the customer was using the pad behind themselves in a recliner.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: michael green
• MDR Report Key: 8963836
• MDR Text Key: 156742828
• Report Number: 1832415-2019-10697
• 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: 08/12/2019

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: 155
• Device Lot Number: 00155325183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/05/2019
• 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