MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA THERATHERM MOISTHEAT PAD SHLDR; PAD, HEATING, POWERED

Model Number	1033
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reporter did not indicate that the device will be returned for evaluation.If the manufacturer receives the device, a supplemental report will be submitted upon completion of the evaluation.
Event or Problem Description
It was reported that the device is overheating during treatment.There was no injury reported.
Additional Manufacturer Narrative
H3, h6: the device was returned for evaluation.Functional test was performed: initial temperature 88°f, final temperature 166°f.During functional test, no temperature issues were found, complaint not confirmed.

• Brand Name: CHATTANOOGA THERATHERM MOISTHEAT PAD SHLDR
• Common Device Name: PAD, HEATING, POWERED
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 8631750
• Report Number: 2020737-2019-00004
• Device Sequence Number: 1925143
• Product Code: IRT
• UDI-Device Identifier: 00888912000154
• UDI-Public: 00888912000154
• Combination Product (Y/N): N
• PMA/510(K) Number: K770686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2019

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
• Operator of Device: Lay User/Patient
• Device Model Number: 1033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 08/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1