MAUDE Adverse Event Report: BATTLE CREEK EQUIPMENT THERMOPHORE

Model Number 055

Device Problems Thermal Decomposition of Device (1071); Smoking (1585); Improper or Incorrect Procedure or Method (2017)

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

Event Type  malfunction  

Event Description

Customer stated, "she was washing the cover slip so she wrapped the pad in a hospital blanket.She laid down, she was tired and her hands hurt.She had her hands under the pad.She was watching tv and dozed off.She said when she dozed off the switch must have been up against her body or the pad or something because the pad stayed on when she fell asleep.She woke up because she smelled smoke.Her pad was smoldering and there was a red smolder running all across the pad.The pad had burnt all the way through the pad.She can see the metal and wires inside the pad.It also, "scored or scorched the blanket." the product has not been returned for investigation.The customer did not claim any injury.The customer was then contacted on 1/10/19, 1/17/19, and finally on 2/1/19 to remind them to return the product for investigation.As of 2/6/2019, the product has not been returned.Without the product, bce cannot make any further determinations.The customer admitted to misusing the pad.The customer had wrapped the pad in a blanket and fell asleep with her hands under the pad.The ifu states, "do not use while sleeping or in bed", and also states "never use pad without cover in place.".

• 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: 8313632
• MDR Text Key: 135853463
• Report Number: 1832415-2019-10019
• 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: 01/07/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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