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

Model Number	27840
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/24/2020
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 "power output is too high, getting 150mw (megawatts) on a 100mw applicator".There was no reported patient harm.No further information is currently available.
Additional Manufacturer Narrative
H3, h6: updated per evaluation report of returned device.Output power was decreased.Applicator was calibrated with a burn-in procedure.Output power was verified to meet device specifications.The device was successfully calibrated and passed full-functional tests as well as burn-in.

• 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: 9805355
• Report Number: 3012446970-2020-00010
• Device Sequence Number: 2704388
• 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,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2020

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
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 03/09/2020
• Supplement 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