MalfunctionDPZ
OXIMAX N-560 PULSE OXIMETER
Received Feb 28, 2014 · Event occurred Feb 3, 2014
Report 2936999-2014-00195 · MDR key 3826524
Product problems
- Mechanical Problem
Patient
Not reported
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
(B)(4). NO PRODUCT RETURNED TO COVIDIEN. A SIMILAR INVESTIGATION HAS BEEN PERFORMED IN 2936999-2013-00113, (B)(4). SERIAL NUMBER PRECEDES A PREVENTIVE ACTION TAKEN BY THE MANUFACTURER.
Description of Event or Problem
CUSTOMER REPORTED THAT THE PULSE WASN'T PROPERLY DISPLAYED WITH SEGMENTS NOT LIT. DISTRIBUTOR CONFIRMED THE FAILURE AND REPLACED THE FRONT PCB BOARD. NO PT WAS INVOLVED.