MalfunctionILJ
SYSTEM 2000
Received Nov 23, 2012 · Event occurred Nov 2, 2012
Report 9611530-2012-00205 · MDR key 2910186
Device
Product problems
- Unstable
Patient
Not reported
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH, INC. ON BEHALF OF THE MANUFACTURER ARJO (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER¿S INESTIGATION.
Description of Event or Problem
AS STATED BY THE CUSTOMER (B)(6) 2012: RHAPSODY, COMPLAINT OF TUB UNSTABLE WHEN FULL. FOUND LOOSE LEG MOUNTING BOLT. REMOVE AND REINSTALL WITH LOCTITE, CHECK OTHER MOUNTING BOLTS. TEST WITH FULL OF WATER, OK.