MalfunctionFTC
HIGH INTENSITY UVA-1
Received Feb 12, 2016 · Event occurred Jan 22, 2016
Report MW5060274 · MDR key 5445269
Product problems
- Break
Patient
68 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
WHILE PT WAS RECEIVING UVA-1 TREATMENT, THE GLASS FILTER ON THE BACK LOWER RIGHT COLUMN SHATTERED. THE SHATTERING NOISE WAS VERY LOUD. GLASS SHARDS WERE MOSTLY CONTAINED BY THE PLASTIC SHIELD, HOWEVER, SOME GLASS SHARDS DID FALL INTO THE CABINET AREA. NO GLASS SHARDS REACHED THE PT. THE FILTERS SHOULD LAST 1000 HOURS. THE ONE INVOLVED WAS ONLY AT 72 HOURS.