MalfunctionDPZ
OXIMAX N-595 PULSE OXIMETER
Received Jun 26, 2014 · Event occurred Jun 1, 2014
Report 2936999-2014-00563 · MDR key 3960781
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
IT WAS REPORTED TO COVIDIEN BY THE BIOMEDICAL ENGINEER THAT THIS N-595 HAS NO AUDIO. THE FACILITY BIOMEDICAL ENGINEER ISOLATED THE ISSUE TO THE MAIN PCB BOARD. THERE WAS NO PT INVOLVEMENT REPORTED.