MalfunctionJIL
CLINITEK STATUS+
Received Jan 2, 2019 · Event occurred Dec 10, 2019
Report 3002637618-2019-00001 · MDR key 8209953
Device
Product problems
- Electrical /Electronic Property Problem
- Electrical /Electronic Property Problem
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
SIEMENS SERVICE STATED THAT THE FUSE WAS REPLACED AND THE PLUG WAS EXCHANGED AND THE INSTRUMENT IS OPERATIONAL. THERE WAS NO HARM DONE TO ANY PATIENT, OPERATOR OR SIEMENS PERSONNEL.
Description of Event or Problem
THE CUSTOMER REPORTED THAT WHEN FIELD SERVICE WAS INSTALLING THE CLINITEK STATUS+, THERE WAS A SHORT CIRCUIT IN THE TWO PARTS OF THE POWER SUPPLY AND THE FUSE BLEW. A PUFF OF SMOKE WAS SEEN. THERE WERE NO PATIENT SAMPLES BEING RUN. THERE WAS NO REPORT OF INJURY DO TO THIS EVENT.