MalfunctionILM
SYSTEM 200
Received Jul 11, 2014 · Event occurred Jun 16, 2014
Report 1419652-2014-00181 · MDR key 3952673
Device
Manufacturer
Arjo Hospital Equipment AbModel number
AP31200-EUProduct problems
- Biofilm coating in Device
- Microbial Contamination of Device
- Environmental Compatibility Problem
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE EVENT IN COMPLAINT (B)(4) HAS DESCRIBED TO US AS FOLLOWS BY THE ARJOHUNTLEIGH REPRESENTATIVE WHO VISITED THE CUSTOMER SITE AND INSPECTED THE DEVICE, AS DOCUMENTED IN THE COMPLAINT FILE: "LEGIONELLA FLUSH PERFORMED". ADDITIONAL INFORMATION PROVIDED BY THE ORIGINATOR. "IT WAS FOUND LOW LEGIONELLA. AFTER FLUSHING RESULT OK". FROM THE INFORMATION RECEIVED THERE IS NO INDICATION THAT ANY INJURY OCCURRED TO THE PATIENT OR CAREGIVER. MFR - 9611530-2014-00048.