SPECTRA 305
Received Aug 2, 1994 · Event occurred Dec 9, 1993
Report 97548 · MDR key 97548
Device
Product problems
- Energy Output To Patient Tissue Incorrect
- Fail-Safe Design Failure
Patient
61 YR
- Burn(s)
- Erythema
- Soreness
Narrative
Description of Event or Problem
PT ENTERED UVB BOOTH WHICH WAS SET AT 400MJ (2:54). PT STARTED UVB. PTA ENTERED THE ROOM TO MONITOR TIME. AT 200 MJ (1.27) UVB HOLD BUTTON WAS PUSHED. PT WAS INSTRUCTED TO PUT PILLOW CASE OVER FACE. RESUME BUTTON WAS PUSHED AND PTA LEFT RROM. CALL LIGHT WAS PULLED BY PT. PTA ENTERED ROOM AND PT STATED, "I THINK I'VE BEEN IN HERE TO LONG!" PTA ATTEMPTED TO PUSH HOLD BUTTON SEVERAL TIMES, BUT UVB LIGHTS WOULD NOT SHUT OFF. PTA LEFT ROOM AND INSTRUCTED PT TO OPEN DOORS, AT WHICH TIME THE LIGHTS SHUT OFF. PT NOTIFIED. AFTER PT LEFT ROOM, PTA SHUT DOORS ON UVB AND LIGHTS CAME BACK ON. THE ONLY WAY LIGHTS COULD BE SHUT OFF WAS TO TURN KEY TO OFF.