inforMED
MalfunctionLIH

INTERFERENTIAL SYS*STIM 220

Received May 16, 2016 · Event occurred Mar 23, 2016

Report 5655572 · MDR key 5655572

Device

Generic name

Interferential Current Therapy

Model number

220

Product problems

  • Temperature Problem

Patient

53 YR

  • Unspecified Infection
  • Partial thickness (Second Degree) Burn
  • Unspecified Infection
  • Partial thickness (Second Degree) Burn

Narrative

Description of Event or Problem

PATIENT SET UP ON IFC (INTERFERENTIAL CURRENT THERAPY) WITHOUT INCIDENT. HE STATED HE HAD NO PAIN AND WAS COMFORTABLE. PATIENT GIVEN A CALL LIGHT AND ENCOURAGED TO PRESS CALL BUTTON IF NEEDING ASSISTANCE DURING THE 15 MIN. TREATMENT. APPROXIMATELY 7 MINUTES INTO TREATMENT, HE FELT THE ELECTRODE WAS GETTING HOT. NO REDNESS OR BLISTERING WHERE ELECTRODES HAD BEEN. ELECTRODES WERE REPOSITIONED AND THERAPY CONTINUED AND WAS COMPLETED WITHOUT OBVIOUS SIGNS OF INJURY. PATIENT SUSTAINED BURN (2ND DEGREE) TO SHOULDER FROM AN ELECTRODE DURING IFC TREATMENT. HE CONTINUES TO TREAT THE SUBSEQUENT INFECTION TO THE SITE. THERE WAS SOME CONJECTURE THAT THE PATIENT USED A TOPICAL PAIN OINTMENT PRESCRIBED BY MD THAT MAY HAVE IMPACTED THE CONDUCTIVITY OF THE ELECTRODES. EQUIPMENT UNDER ANALYSIS BY MANUFACTURER.