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

Model Number 055

Device Problems Hole In Material (1293); Sparking (2595)

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

Event Date 04/07/2014

Event Type  malfunction  

Event Description

Customer called and stated the pad had sparked by a hole in it.

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 misused 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 to following instructions as to the care and handling of the unit.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; fremont IN
• Manufacturer Contact: randy newsome ; 702 south reed st; fremont, IN 46737 ; 2699626181
• MDR Report Key: 3823711
• MDR Text Key: 4390568
• Report Number: 1811605-2014-00105
• 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: 05/01/2014

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: 04/17/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/17/2014
• Initial Date FDA Received: 05/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2002
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1