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

Model Number 055

Device Problem Sparking (2595)

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

Event Date 02/21/2014

Event Type  No Answer Provided  

Event Description

Customer stated that the cord sparked.

Manufacturer Narrative

Our inspection found 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 that the thermostats were discolored, bent/broken.Several leads were bent, loose and broken.Pad was bunched up.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 occurence of this issue.A new jacketed cord design was launched in production on 3/10/2014 that closes (b)(4) pending a future evaluation of the effectiveness of the solution.

• 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: 3784552
• MDR Text Key: 4432891
• Report Number: 1811605-2014-00061
• 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: 055
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/06/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/06/2014
• Initial Date FDA Received: 03/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2002
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1