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

Model Number 055

Device Problems Thermal Decomposition of Device (1071); Hole In Material (1293); Sparking (2595)

Patient Problems Pain (1994); Electric Shock (2554)

Event Date 10/10/2014

Event Type  malfunction  

Event Description

Customer called and stated the cord attaching the unit to the switch frayed and caused an electrical spark that burned a hole though the pt's shirt and caused a painful jolt to the pt.

Manufacturer Narrative

Our inspection found a small cut in the cord near the switch that could have exposed the user to bare wire.The inspection also revealed customer misuse as our inspection found: cord twisted, cord cut/burned strain relief, cracked switch case, pad bunched, bent/broken lead, bent/broken thermostat, thermostat discoloration, pad dirty or stained.This tells us that the pad was not being properly used as per our instructions in the manual.Cord breakage usually occurs when the cord is repeatedly over bent near the switch.We have initiated a capa project (b)(4) to reduce the occurrence of this issue.A new jacketed cord design was launched in production on 03/10/2014 that closes (b)(4) pending a future eval of the effectiveness of the solution.

• 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 southreed st; fremont, IN 46737 ; 2699626181
• MDR Report Key: 4254731
• MDR Text Key: 18797648
• Report Number: 1811605-2014-00218
• 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: 11/05/2014

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: 11/03/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/03/2014
• Initial Date FDA Received: 11/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2012
• 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