MalfunctionDPZ
OXIMAX N-560 PULSE OXIMETER
Received Apr 15, 2014 · Event occurred Mar 20, 2014
Report 2936999-2014-00344 · MDR key 3888086
Product problems
- Component Missing
- Device Displays Incorrect Message
Patient
Not reported
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
(B)(4). COVIDIEN VERIFIED AN INTERMITTENT FAILURE OF THE FRONT PCB AND MAIN PCB BOARDS, THESE PCB BOARDS WERE REPLACED AND THE UNIT PASSED TESTS.
Description of Event or Problem
A N-560 WAS RETURNED TO A COVIDIEN SERVICE CENTER WITH A REPORT OF A DISPLAY ERROR. ON (B)(6) 2014, UPON INVESTIGATION, COVIDIEN DETERMINED THAT THE DISPLAY WAS INTERMITTENTLY MISSING SEGMENTS. THERE WAS NO PT INVOLVEMENT.