MalfunctionFTC
SPECTRA UV THERAPY BOOTH
Received Jun 28, 1994 · Event occurred Apr 11, 1994
Report MW1002622 · MDR key 14371
Device
Product problems
- Nonstandard Device
- Output, high
Patient
47 YR
Narrative
Description of Event or Problem
UNIT FAILED TO TERMINATE AT PRESET TIME AND MILIJOULES ACCORDING TO PT TREATMENT PLAN. PT REPORTED MACHINE WAS GETTING HOT AND THOUGHT HE'D BEEN IN THERE TOO LONG. METER READ 8:11 MINUTES BUT STILL 190 MILIJOULES LEFT. PHYSICIAN EXAMINED PT AND NO APPARENT SYMPTOMS AT THAT TIME. DURING INVESTIGATION IT WAS FOUND THAT THE UNIT HAD AN FDA RECALL IN 1991, FOR THE SAME PROBLEM. THAT WAS 2 YRS BEFORE RPTR PURCHASED UNIT. IT APPEARS THE MFR SOLD RPTR A UNIT THAT WASN'T IN FDA COMPLIANCE.