MalfunctionDPZ
OXIMAX N-560 PULSE OXIMETER
Received Dec 9, 2013 · Event occurred Nov 11, 2013
Report 2936999-2013-00905 · MDR key 3663100
Product problems
- No Display/Image
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
IT WAS REPORTED TO COVIDIEN THAT THE UNIT COULD NOT DISPLAY THE SPO2 AND HEART RATE VALUE CORRECTLY AND RESULTED IN THE ACTUAL VALUE TO NOT BE RECOGNIZABLE. THERE WAS NO PT INVOLVED.
Additional Manufacturer Narrative
COVIDIEN SERVICE VERIFIED THE MISSING SEGMENTS REPORT. THE FRONT PCB WAS REPLACED. THE MANUFACTURE DATE IS UNK FROM THE SERIAL NUMBER PROVIDED. (B)(4).