MalfunctionDPZ
OXIMAX N-595 PULSE OXIMETER
Received Mar 28, 2014 · Event occurred Mar 1, 2014
Report 2936999-2014-00210 · MDR key 3817474
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
RECEIVED A REPORT THS THE N595 HAD NO AUDIO, NO POST (POWER ON SELF-TEST) TONE WAS HEARD WHEN UNIT WAS TURNED ON. CUSTOMER STATED THAT HE WAS ABLE TO ISOLATE THE FAILURE TO THE MAIN PCB OF THE UNIT. NO PATIENT INVOLVEMENT REPORTED.
Additional Manufacturer Narrative
(B)(4). NO PRODUCT WAS RETURNED TO COVIDIEN FOR EVALUATION. CUSTOMER STATED THAT THE MONITOR WILL BE REMOVED FROM HOSPITAL USE.