MalfunctionILM
SYSTEM 2000
Received Jun 27, 2013
Report 9611530-2013-00068 · MDR key 3201518
Device
Manufacturer
Arjo Hospital Equipment AbProduct problems
- Self-Activation or Keying
- Device Inoperable
- Difficult or Delayed Activation
- Infusion or Flow Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
(B)(4).
Additional Manufacturer Narrative
THE REPORT IS BEING SUBMITTED UNDER EXEMPTION (B)(4) BY THE MFR ARJO HOSPITAL EQUIPMENT (B)(4) ON BEHALF OF THE IMPORTER (B)(4). ADD'L INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION.