inforMED
InjuryIMJ

SW-180

Received Mar 17, 2017 · Event occurred Sep 20, 2014

Report 9614750-2017-00007 · MDR key 6412980

Device

Generic name

Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat

Model number

SW-180

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

60 YR

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

Narrative

Description of Event or Problem

THE PATIENT HAD BEEN RECEIVING TREATMENT USING THE SUBJECT DEVICE WITH 40 W OUTPUT IN CONTINUOUS MODE. THE SUBJECT DEVICE BURNT THE PATIENT ON THE HIP DURING THE THIRTEENTH TREATMENT. ACCORDING TO THE HOSPITAL, THE BURN HAD FULLY HEALED BY (B)(6) 2014 WHEN ITO RECEIVED THE INFORMATION ON THE EVENT.

Additional Manufacturer Narrative

ITO EXAMINED THE DEVICE HISTORY RECORD FOR THE DEVICE INVOLVED IN THE ADVERSE EVENT. THERE WERE NO PROBLEMS OBSERVED DURING THE MANUFACTURING OR TESTING NOTED IN THE DHR. ONLY THE OSCILLATOR UNIT WAS RETURNED TO ITO. ITO CONDUCTED THE EVALUATION OF THE RETURNED OSCILLATOR UNIT BUT THERE WAS NO OUTPUT FROM THE UNIT. ITO RECEIVED A REPORT DESCRIBING MISUSE BY THE USER AND DOCUMENTED IT IN THE INVESTIGATION REPORT ON THE SUBJECT DEVICE (S/N (B)(4)). ITO REMINDED THE USER OF THE CORRECT USE OF THE DEVICE, AS DESCRIBED IN THE USER MANUAL.