MalfunctionDPZ
OXIMAX N-560 PULSE OXIMETER
Received Dec 6, 2013 · Event occurred Nov 1, 2013
Report 2936999-2013-00928 · MDR key 3605434
Product problems
- Component Missing
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED TO COVIDIEN THAT THE UNIT DISPLAY BEGAN MISSING SEGMENTS IN THE HEART RATE PORTION OF THE DISPLAY. THERE WAS NO PATIENT HARM.
Additional Manufacturer Narrative
COVIDIEN INVESTIGATION VERIFIED THE UNIT STARTED TO LOSE SEGMENTS INTERMITTENTLY. A VISUAL INSPECTION FOUND A COLD SOLDER JOINT ON ONE OF THE 8-SEGMENT DISPLAY POSTS WHICH COULD CAUSE AN INTERMITTENT FAILURE. THE DISPLAY PCB IS REPLACED. (B)(4).