MAUDE Adverse Event Report: BATTLE CREEK EQUIPMENT THERMOPHORE AUTOMATIC HEAT PACK; ELECTRIC MOIST HEAT PACK

Model Number 055

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 03/17/2014

Event Type  malfunction  

Event Description

Customer recently noticed a burn mark on the outer protective sheet they put over the pad.Took off all of the coverings and the actual pad had burned through everything and even onto their therapy bed.

Manufacturer Narrative

Our examination revealed that one of the terminals had been broken near a thermostat, which had compromised our double-insulated design.We also found several other internal components that were damaged, indicating that the customer misuse the pad by applying an excessive, localized force on or near the thermostat terminal.We concluded that this report was attributable to misuse by the user, and failure ot follow instructions as to the care and handling of the unit.After investigation qx noted the following: pad appears to have been used in a roller bed.Outline of hw and lead on cover, front and back.Pad bunches, bent/broken lead, burn - harness.Although warning labels and instruction booklets warn against sitting or laying on the product, we have a corrective action project (b)(4) underway to make the design more robust.

• Brand Name: THERMOPHORE AUTOMATIC HEAT PACK
• Type of Device: ELECTRIC MOIST HEAT PACK
• Manufacturer (Section D): BATTLE CREEK EQUIPMENT; freemont IN
• Manufacturer Contact: randy newsome ; 702 south reed street; freemont, IN 46737 ; 2699626181
• MDR Report Key: 3788434
• MDR Text Key: 20265779
• Report Number: 1811605-2014-00084
• 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,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/01/2014

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: Lay User/Patient
• Device Model Number: 055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/24/2014
• Initial Date FDA Received: 04/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1