MalfunctionDPZ
OXIMAX N-560 PULSE OXIMETER
Received Feb 28, 2014 · Event occurred Feb 3, 2014
Report 2936999-2014-00143 · MDR key 3826525
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
CUSTOMER REPORTED THAT THEY WERE MISSING 7-SEGMENTS OF HEART RATE VALUE ON FRONT PCB. DISTRIBUTOR CONFIRMED THE FAILURE TO BE THE SPO2 (SATURATION) SIDE OF THE MONITOR, AND REPLACED THE FRONT PCB BOARD. NO PT WAS INVOLVED.
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.