MalfunctionILM
PARKER BATH
Received Sep 12, 2013 · Event occurred Jan 1, 2013
Report 1419652-2013-00252 · MDR key 3403147
Device
Manufacturer
Arjo Hospital Equipment AbModel number
AL11511-GBProduct problems
- Biofilm coating in Device
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
THE PARKER BATH IS A BATH SYSTEM INTENDED FOR ASSISTED BATHING. IT WAS REPORTED TO US THAT LEGIONELLA WAS FOUND IN TWO PARKER BATHS. THE BRAND NEW FACILITY HAS INSTALLED TWO LEGACY PARKER BATHS AND SINCE THEN HAD REOCCURRING PROBLEMS WITH TOO HIGH LEGIONELLA COUNTS (AS HIGH AS 10,000 CFU/LTR) SPECIFICALLY RELATED TO THESE 2 BATHS. (B)(4).