MAUDE Adverse Event Report: BATTLE CREEK MANUFACTURERS, INC. THERMOPHORE AUTOMATIC HEAT PACK; ELECTRIC MOIST HEAT PACK

Model Number 155

Device Problem Fire (1245)

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

Event Date 02/21/2014

Event Type  malfunction  

Event Description

Consumer stated that she turned pad on and it sparked.Had a flame like a lighter.

Manufacturer Narrative

Analysis of the switch components revealed that sensitivity to external stress had caused the failure of a resistor.The failure resulted in a small spark that was contained by our double-insulted design.Although this is not a statistically significant complaint and may be due to misuse or failure to follow instructions of the part of the consumer, we have initiated the following corrective actions: we have reinforced the terminals leading into the switch to reduce the possibility of current fluctuations and/or open continuity.We are investigating the possibility of repositioning components to reduce the possibility of accidental contact within the switch-case.

• Brand Name: THERMOPHORE AUTOMATIC HEAT PACK
• Type of Device: ELECTRIC MOIST HEAT PACK
• Manufacturer (Section D): BATTLE CREEK MANUFACTURERS, INC.; battle creek MI
• Manufacturer Contact: randy newsome ; 702 s reed str; fremont, IN 76737 ; 2699626181
• MDR Report Key: 3716492
• MDR Text Key: 4335570
• Report Number: 1811605-2014-00064
• 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: 03/24/2014

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: 155
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/10/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2014
• Initial Date FDA Received: 03/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1