MAUDE Adverse Event Report: DJO LLC. CHATTANOOGA APPLICATOR SINGLE 850NM 100MW; LAMP, INFRARED, THERAPEUTIC HEATING

Model Number	27840
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/06/2020
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 the "output was too high, requires calibration." there was no reported patient harm.No further information is currently available.

• Brand Name: CHATTANOOGA APPLICATOR SINGLE 850NM 100MW
• Common Device Name: LAMP, INFRARED, THERAPEUTIC HEATING
• Manufacturer (Section D): DJO LLC.; 1430 decision street; vista, ca
• MDR Report Key: 9964811
• Report Number: 3012446970-2020-00016
• Device Sequence Number: 14138324
• Product Code: ILY
• UDI-Device Identifier: 00888912293990
• UDI-Public: 00888912293990
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K040662
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/15/2020

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: 27840
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1