MalfunctionFLS
SMART MONITOR 2
Received Nov 26, 2018 · Event occurred Nov 1, 2018
Report 3006182632-2018-00028 · MDR key 8102283
Device
Product problems
- Solder Joint Fracture
- Solder Joint Fracture
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THIS MONITOR IS THE HOME VERSION OF THE SMART MONITOR 2 AND THE JACK ON THE BACK OF THE MONITOR IS FOR INTERFACING TO A PREVIOUSLY SOLD REMOTE ALARM FOR HOME USE. THIS JACK IS NOT OPERABLE WITH A NURSE CALL SYSTEM. THE USER FACILITY HAS BEEN INFORMED THAT THIS INTERFACE SHOULD NOT BE USED WITH A NURSE CALL SYSTEM AS IT IS NOT INTENDED FOR THAT PURPOSE.
Description of Event or Problem
A USER FACILITY REPORTED THAT THE NURSE CALL JACK ON THE MONITOR WAS NOT FUNCTIONING PROPERLY.
Remedial action
- Repair