MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA APPLICATOR 13CLS 3X200MW 715MW; LAMP, INFRARED, THERAPEUTIC HEATING

Model Number 27816

Device Problem Overheating of Device (1437)

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

Event Date 01/22/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter information: unknown.No device was returned for evaluation.If the device is received, a follow-up report will be submitted upon completion of product evaluation.

Event Description

It was reported that the "output is hot and causing customer to pull away from treatment." there was no reported patient harm.

Manufacturer Narrative

Updated to reflect new point-of-contact.Device was returned for evaluation.The device passed the calibration tests/checks and the reported incident could not be duplicated.

• Brand Name: CHATTANOOGA APPLICATOR 13CLS 3X200MW 715MW
• Type of Device: LAMP, INFRARED, THERAPEUTIC HEATING
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081
• Manufacturer (Section G): DJO, LLC; 3151 scott st.; vista CA 92081
• Manufacturer Contact: christine bonczyk ; 2900 lake vista drive; lewisville, ca, TX 75067
• MDR Report Key: 9659421
• MDR Text Key: 182180741
• Report Number: 3012446970-2020-00002
• Device Sequence Number: 1
• Product Code: ILY
• UDI-Device Identifier: 00888912293891
• UDI-Public: 00888912293891
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K040662
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1