MAUDE Adverse Event Report: BATTLE CREEK EQUIPMENT THERMOPHORE

Model Number 055

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017); Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Customer stated, "i trying to turn on the switch and it spark at the switch.Now it doesn't work.Then she said the switch cover fell apart as well." the product was returned for investigation.The customer did not claim any injury.The product was approx.4 years old when the incident occurred.An investigation was done to look into the customers complaint.The pad was sent back with a switch that had been torn apart.The inside of the switch showed signs that it had sparked.This incident was caused from customer misuse.The customer was wrapping the cord under the switch, causing the cord to twist and the internal components of the switch to come in close proximity of each other, which is what caused the spark.Ifu states "loop cord loosely when storing.Tight wrapping may damage cord and internal parts." the pad had a noticeable odor, and was stained and bunched.

• 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: 8265659
• MDR Text Key: 134361390
• Report Number: 1832415-2019-09979
• 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: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2019
• 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: 0554914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• 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