inforMED
MalfunctionILM

MALIBU/SOVEREIGN(INCL.DIGNITY)

Received Jun 13, 2013

Report 1419652-2013-00161 · MDR key 3185227

Device

Manufacturer

Arjo, Inc.

Model number

AZL22010-GB

Product 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).