inforMED
MalfunctionILM

SYSTEM 2000

Received Jul 22, 2013

Report 9611530-2013-00089 · MDR key 3251897

Device

Product problems

  • Material Separation

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

THE REPORT IS BEING SUBMITTED UNDER EXEMPTION (B)(4) BY THE MFR ARJO (B)(4) ON BEHALF OF THE IMPORTER (B)(4). ADD'L INFO WILL BE PROVIDED UPON COMPLETION OF THE MFR'S INVESTIGATION.

Description of Event or Problem

(B)(4).