MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA HYDROCOLLATOR, M-4, C/W 24 STD. PACKS; UNIT, HEATING, POWERED

Model Number	2502
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device was returned for evaluation.If the device is received, a follow-up report will be submitted upon completion of product evaluation.
Event or Problem Description
It was reported that "physical inspection revealed neutral prong on cord was melted.[r]receptacle was melted as well and neutral prong fell off.[i]internal wiring has evidence of heat damage".There was no reported patient harm.
Additional Manufacturer Narrative
One (b)(6) hydrocollator, m-4, c/w 24 std.Packs, serial number (b)(6), was returned for evaluation.A loose contact in the fuse bracket created resistance, which overheated the electric circuit leading to the reported event.The international electrotechnical commission (iec) connector, thermostat, fuse bracket, pilot light, power cable, and all wiring were replaced.A full functional test was then performed.

• Brand Name: CHATTANOOGA HYDROCOLLATOR, M-4, C/W 24 STD. PACKS
• Common Device Name: UNIT, HEATING, POWERED
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081
• MDR Report Key: 9529950
• Report Number: 9616086-2019-00090
• Device Sequence Number: 2408327
• Product Code: IRQ
• UDI-Device Identifier: 00888912021463
• UDI-Public: 00888912021463
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2019

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: Health Professional
• Device Model Number: 2502
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 12/30/2019
• Supplement Report FDA Received Date: 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1