MalfunctionDPZ
OXIMAX N-560 PULSE OXIMETER
Received May 5, 2014 · Event occurred Jan 13, 2014
Report 2936999-2014-00397 · MDR key 3901649
Product problems
- No Display/Image
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). THE FAULT WAS FOUND WITH THE FRONT PCB BOARD, AND THE FRONT PCB BOARD WAS REPLACED. THE MANUFACTURE DATE OF THE PRODUCT PRECEDES A SUPPLIER CORRECTIVE AND PREVENTIVE ACTION TAKEN BY THE MANUFACTURER FOR THIS REPORTED FAILURE.
Description of Event or Problem
COVIDIEN-(B)(4) SERVICE CENTER RECEIVED A REPORT OF AN N-560 THAT COULD NOT DISPLAY THE SEGMENTS OF THE SATURATION VALUE. THE FAILURE HAPPENED WHEN THE DEVICE WAS NOT BEING USED ON A PATIENT.