inforMED
InjuryIMI

ME718

Received Jan 18, 2017 · Event occurred Jan 20, 2016

Report 9614750-2017-00005 · MDR key 6261314

Device

Generic name

Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

Model number

US-101L

Product problems

  • Device Operates Differently Than Expected
  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

68 YR

  • Burn(s)
  • Swelling
  • Injury
  • Partial thickness (Second Degree) Burn
  • Burn(s)
  • Swelling
  • Injury
  • Partial thickness (Second Degree) Burn

Narrative

Additional Manufacturer Narrative

UPON RECEIPT OF THE DEVICE INVOLVED IN THE ADVERSE EVENT, ITO CONDUCTED A FAILURE ANALYSIS OF THE RETURNED DEVICE: ITO INSPECTED THE APPEARANCE OF THE RETURNED DEVICE AND OBSERVED FINE SCRATCHES ON THE SURFACE AND CORROSION IN THE CENTER OF THE OSCILLATOR. ITO CONDUCTED THE FOLLOWING INSPECTIONS ON THE RETURNED DEVICE: - MEASUREMENT OF OSCILLATORY FREQUENCY: WITHIN THE PRE-DEFINED SPECIFICATIONS - MEASUREMENT OF POWER INPUT: WITHIN THE PRE-DEFINED SPECIFICATIONS - MEASUREMENT OF ULTRASOUND OUTPUT: WITHIN THE PRE-DEFINED SPECIFICATIONS - SAFETY EQUIPMENT: FUNCTIONED AS PRE-DEFINED - FAN MOTOR: FUNCTIONED AS PRE-DEFINED - SHOCK TEST: PASSED - LOAD TEST: PASSED - ENVIRONMENT TEST: PASSED - MEASUREMENT OF ERA: WITHIN THE PRE-DEFINED SPECIFICATIONS - MEASUREMENT OF BNR: WITHIN THE PRE-DEFINED SPECIFICATIONS ITO SAVED ALL THE DATA IN THE INVESTIGATION REPORT ON US-101L (S/N: (B)(4)). CONCLUSION REACHED BASED ON THE INVESTIGATION AND ANALYSIS RESULT: THE SUBJECT DEVICE FUNCTIONS WITHOUT ANY ABNORMALITY. ITO REMINDED THE USER OF THE CORRECT USAGE, AS DESCRIBED IN THE USER MANUAL. THE HEALTHCARE FACILITY DID NOT DISCLOSE THE INFORMATION ON THE PATIENT'S WEIGHT.

Additional Manufacturer Narrative

THIS EVENT INVOLVING US-101L DEVICE OCCURRED IN (B)(6), BUT SIMILAR DEVICE IS MARKETED IN THE US UNDER THE BRAND NAME ME718.

Description of Event or Problem

ULTRASOUND WAS APPLIED TO THE PATIENT'S HIP USING THE SUBJECT US-101L DEVICE AT 100% OUTPUT ON 2.00W/CM2 WITH 1MHZ FREQUENCY. THE APPLICATION WAS MADE FOR ONE MINUTE TO ONE AND A HALF MINUTES ON EACH SPOT, AND THE TOTAL APPLICATION TIME WAS FIVE MINUTES. THE ELECTRODES WERE USED IN A STROKING MOTION WITHIN A 2CM WIDTH. THE PROCEDURE STATED TO CHANGE THE APPLICATION SPOT UPON ANY ALLEGED DISCOMFORT OR PAIN BY A PATIENT. THERE WAS NO HEAT SENSATION ALLEGED BY THE PATIENT DURING THE TREATMENT. THERE WAS NO BLISTER OBSERVED AFTER THE TREATMENT, BUT A BLISTER WAS CONFIRMED A FEW DAYS LATER UPON RECEIVING A COMPLAINT FROM THE PATIENT.