inforMED
MalfunctionIMI

SOLARIS 709 PLUS

Received Aug 5, 2025 · Event occurred Jul 14, 2025

Report MW5174064 · MDR key 22719935

Device

Generic name

Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

Manufacturer

Dynatronics Corp

Product problems

  • Use of Incorrect Control/Treatment Settings
  • Overheating of Device
  • Therapeutic or Diagnostic Output Failure

Patient

45 YR · Male

  • Inflammation
  • Pain
  • Ambulation or Postural Difficulties
  • Hyperresponsive to stimuli
  • Inflammation
  • Pain
  • Ambulation or Postural Difficulties
  • Hyperresponsive to stimuli

Narrative

Description of Event or Problem

PATIENT WAS SEEN BY (B)(6), PT (PHYSICAL THERAPISTS) ON (B)(6) 2025 AT 13:45PM FOR FOURTH FOLLOW UP VISIT. PATIENT ARRIVED REPORTING THAT THE FEET HURT A LOT TODAY AFTER STANDING A LOT FOR WORK AND LIFTING AND REQUESTED TO KEEP TREATMENT LIGHT. WAS DOING WELL BEFORE BUT HAD BEEN ON FEET A LOT MORE IN THE LAST WEEK. PATIENT AGREED TO TRIALING ULTRASOUND DUE TO LOCAL NATURE OF PAIN. PT EDUCATED PATIENT ON PURPOSE OF ULTRASOUND AND EXPECTED SENSATION DURING TREATMENT, PATIENT AGREED. PT AIDE, (B)(6), BROUGHT IN THE ULTRASOUND MACHINE. PT APPLIED THE SETTINGS: 3 MHZ, 1 WCM2, 100% AND INSTRUCTED AIDE TO PERFORM ONTO L (LEFT) SPRING LIGAMENT REGION. AFTER PT (PHYSICAL THERAPY) AIDE APPLIED GEL AND WAS ABOUT TO BEGIN, PT NOTICED PT AIDE WAS USING LARGE SOUND HEAD AND AIDE WAS INSTRUCTED TO SWITCH TO THE SMALL SOUND HEAD DUE TO LOCALIZED NATURE OF PAIN. PT MONITORED PT AIDE IN BEGINNING TREATMENT, INITIALLY PT AIDE WAS PERFORMING NEAR 1ST METATARSAL, PT AIDE INSTRUCTED TO PERFORM AT SPRING LIGAMENT REGION INSTEAD WITH SMALL CIRCLES AND ENOUGH GEL APPLIED. THREE MINUTES INTO TREATMENT, PATIENT STATED THAT THE SOUNDHEAD STARTED TO GET HOT. PT CHECKED THE SETTINGS AND NOTICED THAT THE INTENSITY HAD JUMPED FROM 1.0 W/CM2 TO 2.5 W/CM2. PT STOPPED THE TREATMENT IMMEDIATELY AND VISUALLY INSPECTED THE SKIN AND DID NOT FIND ANY BURNS OR COLOR CHANGES IN THE FOOT. THE PATIENT STATED THAT THE FOOT HAD INCREASED DISCOMFORT AS A RESULT OF OVERALL TREATMENT. PT EDUCATED PATIENT ON REDUCING ACTIVITY LEVEL AND USE OF ICE IF THE FOOT CONTINUED TO BE INFLAMED. PATIENT AGREEABLE. PT NOTIFIED SUPERVISOR OF THE INCIDENT AND A TICKET WAS SUBMITTED TO GE TO HAVE ULTRASOUND EQUIPMENT ASSESSED. ON (B)(6) THE PATIENT SENT MHO DIRECT MESSAGE, "HI, I AM IN A LOT OF PAIN TODAY AFTER OUR VISIT YESTERDAY. MAYBE THE SCRAPPING OR ULTRASOUND JUST MADE IT REALLY BAD WHERE IT'S VERY HARD TO WALK. ANY SUGGESTIONS BESIDES NOT WALKING?". PT RESPONDED BY SAYING TO CONTINUE TO ICE MASSAGE TO REDUCE INFLAMMATION AND ADDED INSTRUCTIONS TO (B)(6). PATIENT EXPRESSED GRATITUDE. ON (B)(6) THE PATIENT SEND ANOTHER MHO DIRECT MESSAGE, "DO YOU THINK ANYTHING FROM THE PT COULD HAVE WORSENED MY PROBLEMS I'M AT ABOUT A 10 ON THE PAIN SCALE AND IT WAS AND HAS BEEN SIGNIFICANTLY WORSE SINCE WE SEEN EACH OTHER AND THE SCRAPING / ULTRASOUND TREATMENT". PT RESPONDED AND STATED THAT THE FOOT WAS FLARED AT THE START OF TREATMENT AND IT FURTHER DID NOT RESPOND WELL TO THE PRESSURE OR HEAT. IT MOST LIKELY WOULD NOT CAUSE A 10/10 PAIN THOUGH THAT REGION SEEMS TO BE HYPERSENSITIVE. PATIENT WAS INSTRUCTED TO FOLLOW UP WITH MD FOR FURTHER EVALUATION. ALSO INSTRUCTED ON SHOE WEAR AND PAIN MANAGEMENT STRATEGIES. PT SUBMITTED A MIDAS REPORT DOCUMENTING THE INCIDENT. ON (B)(6) SOMEONE FROM GE CAME TO ASSESS THE MACHINE AND FOUND THAT THE MACHINE WAS WORKING WELL. (B)(6) WAS PRESENT FOR A SHORT PERIOD WHEN HE FOUND THAT THE SETTING JUMPED FROM 1.0 TO 2.5 W/CM2 WHEN THE SOUNDHEAD WAS SWITCHED FROM THE LARGE TO SMALL SOUNDHEAD. PT AIDE, (B)(6), RELAYED MESSAGE FROM THE GE TECH SAID "THE MACHINE IS WORKING WELL. THE ONLY THING THAT WE NEED TO DO WHEN GOING FROM THE BIG ULTRASOUND HEAD TO THE SMALL ONE IS TO RESET THE MACHINE BECAUSE THE SMALL HEAD COMPENSATING FOR THE OUTPUT THAT THE BIG GIVES OFF THE SAME BUT IN A SMALLER FOCAL POINT." ON (B)(6), PT AIDE (B)(6) LOOKED THROUGH INSTRUCTION MANUAL ON DYNATRONIC UNITS AND STATED, "I COULD NOT FIND ANY INFORMATION IN THE MANUAL OR ON THEIR WEBSITE STATING THAT THE UNITS SHOULD BE TURNED OFF BEFORE SWITCHING SOUND HEADS." ACTION: ALL PT AIDES AND PROVIDERS WERE INFORMED OF THESE FINDINGS AND NEW PROTOCOL. ALL UNITS WILL NOW BE POWERED OFF WHEN SWITCHING SOUND HEADS AS A PRECAUTION, EVEN THOUGH NOT INSTRUCTED IN MANUAL.