inforMED
InjuryIMG

SONICATOR PLUS 940

Received Apr 5, 2017 · Event occurred Jan 11, 2017

Report 9614750-2017-00008 · MDR key 6462422

Device

Generic name

Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

Model number

ME940

Product problems

  • Degraded
  • Material Integrity Problem
  • Physical Property Issue
  • Insufficient Device Problem Information
  • Degraded
  • Material Integrity Problem
  • Physical Property Issue

Patient

53 YR

  • Burn(s)
  • Swelling
  • Injury
  • Burn(s)
  • Swelling
  • Injury

Narrative

Description of Event or Problem

THE PATIENT WAS TREATED WITH THE SUBJECT DEVICE WITH QUADRUPOLE INTERFERENCE WAVE AT 70MA OUTPUT FOR FIFTEEN MINUTES. THE PATIENT NOTICED A BLISTER ON THE UPPER ABDOMINAL AREA AFTER THE TREATMENT.

Additional Manufacturer Narrative

UPON RECEIPT OF THE DEVICE INVOLVED IN THE ADVERSE EVENT, ITO CONDUCTED A FAILURE ANALYSIS OF THE RETURNED DEVICE. INSPECTION OF THE MAIN UNIT RETURNED: HIGH VOLTAGE TEST: PASSED. MEASUREMENT OF LEAKAGE CURRENT: WITHIN THE PRE-DEFINED SPECIFICATIONS. MEASUREMENT OF POWER INPUT: WITHIN THE PRE-DEFINED SPECIFICATIONS. MEASUREMENT OF OUTPUT VOLTAGE: WITHIN THE PRE-DEFINED SPECIFICATIONS. MEASUREMENT OF OUTPUT CURRENT: WITHIN THE PRE-DEFINED SPECIFICATIONS. MEASUREMENT OF FREQUENCE: WITHIN THE PRE-DEFINED SPECIFICATIONS. MEASUREMENT OF PROTECTIONAL GROUND RESISTANCE: WITHIN THE PRE-DEFINED SPECIFICATIONS. TEST ON SAFETY MECHANISM: PASSED. TEST ON OVER-CURRENT DETECTION FUNCTION: PASSED. MEASUREMENT OF ULTRASOUND OUTPUT: WITHIN THE PRE-DEFINED SPECIFICATIONS. TEST ON LED LAMP: PASSED. TEST ON FAN MOTOR: PASSED. TEST ON BUZZER: PASSED. TEST ON UNIT DISPLAY: PASSED. INSPECTION OF CONSUMABLE ACCESSORIES RETURNED: INSPECTION ON VISCOSITY OF THE ELECTRODE SURFACE: DETERIORATION OBSERVED. CONCLUSION: ITO CONCLUDED BASED ON THE ANALYSIS THAT THE ELECTRODES WITH DETERIORATED SURFACE MAY HAVE RESULTED IN THE CONCENTRATION OF ELECTRIC CURRENT, WHICH CAUSED THE PATIENT'S BURN. IN ORDER TO PREVENT THE RECURRENCE, ITO REMINDED THE USER TO FOLLOW THE INSTRUCTION FOR USE CONTAINED IN THE USER MANUAL INCLUDING THE REPLACEMENT OF ELECTRODES BEFORE DETERIORATION OF THE SURFACE.