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

Model Number 27840

Device Problem Power Problem (3010)

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

Event Date 02/24/2020

Event Type  malfunction  

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 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.

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
• Type of Device: LAMP, INFRARED, THERAPEUTIC HEATING
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista, ca
• MDR Report Key: 9805355
• MDR Text Key: 193089349
• Report Number: 3012446970-2020-00010
• Device Sequence Number: 1
• Product Code: ILY
• UDI-Device Identifier: 00888912293990
• UDI-Public: 00888912293990
• Combination Product (y/n): N
• PMA/PMN Number: K040662
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 03/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27840
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1