MalfunctionILY
ANODYNE THERAPY PROFESSIONAL SYSTEM
Received Jun 8, 2011 · Event occurred May 19, 2011
Report MW5020967 · MDR key 2127004
Device
Product problems
- Energy Output To Patient Tissue Incorrect
- Self-Activation or Keying
Patient
75 YR
- Burn, Thermal
Narrative
Description of Event or Problem
OT PLACED PADS ON PT AND BRIEFLY LEFT ROOM. WHEN OT RETURNED, THE UNIT APPEARED TO HAVE SPONTANEOUSLY INCREASED ITS INTENSITY. AREA ASSESSED FOR SKIN INTEGRITY, AND REDDENED AREA NOTED ON RIGHT SCAPULA. PT DENIED PAIN OR DISCOMFORT AT TIME. INFRARED UNIT HAD BEEN CALIBRATED PER GUIDELINES. UNIT SENT TO MANUFACTURER FOR EVALUATION.