SOLARIS UNIT D708 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-07-12 for SOLARIS UNIT D708 * manufactured by Dynatronics.

Event Text Entries

[2833088] Patient had been seen multiple times with ultrasound used. Setting was continuous 1. 5 watts/centimeter squared 3 megahertz at l lateral hamstring tendon in area of increased tissue density. At no time was the sound head still or removed from contact until at approximately 3 minutes of use patient reported it was very hot. At the same time, therapist noted that the intensity setting on machine was blinking. When patient reported ultrasound was hot, sound head was immediately removed. Patient reported that it felt fine after removal. Pinkness noted but no burns or other skin irritation. Setting was then changed for 1. 2 watts/centimeter squared and restarted at otherwise the same settings. Within 30 seconds, machine was noted to be blinking the intensity setting once again though patient reported no pain or discomfort. Ultrasound was immediately terminated and removed. Gel was removed from skin and there was no tenderness with palpation. Pinkness dissipated. No pain or discomfort with active knee curls. Ultrasound machine was removed from service. A different ultrasound was then used for another 4 minutes at the same settings for 1. 2 watts/centimeter squared. Patient had no problems and reported that this machine did not have the warmth of the other machine. Tissue density did improve with this machine. No pinkness. Continued session with exercises with no complaints. Patient reported no pain or discomfort or questions at end of session.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2661647
• MDR Report Key: 2661647
• Date Received: 2012-07-12
• Date of Report: 2012-07-12
• Date of Event: 2012-05-09
• Report Date: 2012-07-12
• Date Reported to FDA: 2012-07-12
• Date Added to Maude: 2012-07-19
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SOLARIS UNIT
• Generic Name: ULTRASONIC THERAPY DEVICE
• Product Code: IMI
• Date Received: 2012-07-12
• Model Number: D708
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DYNATRONICS
• Manufacturer Address: 7030 PARK CENTRE DR. SALT LAKE CITY UT 84121 US 84121

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-07-12