MAUDE Adverse Event Report: BATTLE CREEK EQUIPMENT THERMOPHORE

Model Number 055

Device Problems Thermal Decomposition of Device (1071); Improper or Incorrect Procedure or Method (2017); Sparking (2595)

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

Event Type  malfunction  

Event Description

Customer stated "she was laying on the pad when the control started sparking." the customer did not seek out medical attention.Product was returned for investigation.This pad was manufactured in 2009, the product was approx.7 years and 7 months old when the incident occurred.Upon further investigation into the customers complaint, the inspector found that the cord had a small burn right by the strain relief which is the probable cause of sparking.Based on the bce review of feedbacks, bce did not observe a similar issue within the lot.The customer was also misusing the pad.The customer admitted that she was laying on the pad when the control started sparking.Ifu states "do not sit on, lie on, or crush pad.Avoid sharp folds".

• Brand Name: THERMOPHORE
• Type of Device: THERMOPHORE
• Manufacturer (Section D): BATTLE CREEK EQUIPMENT; 702 s reed rd; fremont IN 46737
• Manufacturer Contact: uday bahal
• MDR Report Key: 7193889
• MDR Text Key: 97954439
• Report Number: 1832415-2017-07887
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/16/2017

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: No Information
• Device Model Number: 055
• Device Lot Number: 092660
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1