MAUDE Adverse Event Report: BATTLE CREEK EQUIPMENT THERMOPHORE DEEP-HEAT THERAPY; 055 STANDARD THERMOPHORE

Model Number 055

Device Problems Break (1069); Thermal Decomposition of Device (1071); Improper or Incorrect Procedure or Method (2017); Electrical Shorting (2926)

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

Event Date 03/07/2014

Event Type  Other  

Event Description

I used this heating pad while sitting in a chair with the pad placed between my back and the chair back.When i pressed the lever to heat the pad, the cord shorted, burned at the switch, shot out a yellow flame and severed the cord at the switch.I called the company and they sent out a new pad as a replacement.The new pad (serial# (b)(4)) has a single thick vs a double thin cord that was on the old pad.Per the company's request, i returned the original pad to them in the new pad's box ((b)(4)).The company was very co-operative.If there are other pads with the double wire thin cord and someone is in bed or close to combustible materials, there could be a risk of a serious burn and potential of fire.(b)(4).

• Brand Name: THERMOPHORE DEEP-HEAT THERAPY
• Type of Device: 055 STANDARD THERMOPHORE
• Manufacturer (Section D): BATTLE CREEK EQUIPMENT; 702 s reed rd; fremont IN 46737
• MDR Report Key: 3803054
• MDR Text Key: 20008866
• Report Number: MW5035965
• Device Sequence Number: 1
• Product Code: IRT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 055
• Patient Sequence Number: 1
• Patient Age: 65 YR