MalfunctionILM
MALIBU/SOVEREIGN(INCL.DIGNITY)
Received Jun 13, 2013
Report 1419652-2013-00161 · MDR key 3185227
Device
Manufacturer
Arjo, Inc.Model number
AZL22010-GBProduct problems
- Microbial Contamination of Device
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE ISSUE OCCURRED IN A MALIBU/SOVEREIGN, A BATH SYSTEM FOR ASSISTED BATHING AND AS REPORTED FROM THE CUSTOMER, THEY HAVE PROBLEMS WITH VERY HIGH COUNTS OF PSEUDOMONAS SPECIES AND PSEUDOMONAS AERUGINOSA. THE SAMPLING FROM THE BATH TAP WAS FINE BUT FROM THE BATH SHOWER THEY ARE HAVING THE PROBLEMS WITH HIGH COUNTS. THE SHOWER HOSE AND SHOWERHEAD HAS ALREADY BEEN CHANGED BUT THEY ARE STILL HAVING PROBLEMS. WHEN THIS WAS DONE IT WAS NOTICED THAT THE RESERVOIR WAS FULL OF SCUM EVEN THOUGH THIS HAD ALREADY BEEN CHANGED. (B)(4).