MAUDE Adverse Event Report: HEMI THERMOPHORE AUTOMATIC HEAT PACK; ELECTRIC MOIST HEAT PACK

Model Number 055

Device Problem Thermal Decomposition of Device (1071)

Patient Problem Burn(s) (1757)

Event Date 03/19/2014

Event Type  malfunction  

Event Description

Caller stated that the cord burned at the switch and burned little finger.

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.Our investigation found that it appears that the switch case was cracked and the customer put a piece of tape over it continued to use it and got a spark from it.

• Brand Name: THERMOPHORE AUTOMATIC HEAT PACK
• Type of Device: ELECTRIC MOIST HEAT PACK
• Manufacturer (Section D): HEMI; fremont IN
• Manufacturer Contact: randy newsome ; 702 south reed street; fremont, IN 46737 ; 2699626181
• MDR Report Key: 3788433
• MDR Text Key: 4442147
• Report Number: 1811605-2014-00085
• 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
• 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