inforMED
MalfunctionILY

ANODYNE THERAPY

Received Oct 20, 2008 · Event occurred Aug 7, 2008

Report MW5008688 · MDR key 1205865

Device

Generic name

Infrared Unit Pads

Model number

480

Product problems

  • False Device Output
  • Replace

Patient

78 YR

  • Injury
  • Burn, Thermal

Narrative

Description of Event or Problem

INCONSISTENT POWER TO 1 SET OF PADS REGARDLESS OF PLACEMENT IN UNIT. ALL OTHER PADS APPEARED NORMAL REGARDLESS OF PLACEMENT. RESIDENT PRESENTED WITH BURN -PINKISH BLOOD VESSELS VISIBLE THROUGH SKIN- AT LOCATION OF ANODYNE PAD PLACEMENT ON UPPER ARM. THIS PIECE OF EQUIPMENT WAS RETURNED TO THE VENDOR/MFR AND REPLACED. THE FACILITY EXPERIENCED 2 MORE 'BURN-LIKE' INJURIES TO 2 OTHER RESIDENTS - BOTH EVENTS IN 2008 RESULTING DURING ANODYNE THERAPY. ONE WAS DETERMINED TO BE CAUSED BY PAD PLACEMENT NEAR BONY PROMINENCE AND THE OTHER RESOLVED WITHIN A DAY BUT D/T THESE PREVIOUS INCIDENTS INVOLVING THE SAME ANODYNE THERAPY EQUIPMENT AND THE PT PULLING THE UNIT OFF THE TABLE, IT WAS LOCKED OUT FOR TESTING AND CALIBRATION. THESE INCIDENTS WERE NOT BELIEVED TO BE CAUSED BY A MALFUNCTION OR DEFECT OF THE EQUIPMENT.