MAUDE Adverse Event Report: BATTLE CREEK EQUIPMENT THERMOPHORE

Model Number 055

Device Problems Thermal Decomposition of Device (1071); Overheating of Device (1437); Improper or Incorrect Procedure or Method (2017); Material Twisted/Bent (2981)

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

Event Type  malfunction  

Event Description

Customer stated "as the pad was in use on a bed, the junction of where the cord meets the switch was in contact with the floor.It malfunctioned and caused the burn [on the floor]." the product was returned for investigation.An investigation was done into the customers complaint.The inspector found that the cord had been pulled from the switch.The customer had tried fixing the cord by wrapping it with electrical tape.Ifu states "carefully examine before each use.Discard unit if it shows signs of deterioration." pad was folded or laid on during use.Ifu states "do not sit on, lie on, or crush pad.Avoid sharp folds".No burn marks were observed on the heating pad.Inspector also observed that the cord inside the switch was twisted.Customer did not claim any injury based on the bce review of feedbacks, bce did not observe a similar issue within the lot.

• 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: 7282363
• MDR Text Key: 100659041
• Report Number: 1832415-2017-08644
• 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: 11/30/2017

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: 0550915
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/20/2018
• 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