CLINITEK STATUS+
Received Mar 28, 2024 · Event occurred Feb 27, 2024
Report 3002637618-2024-00024 · MDR key 18995043
Device
Product problems
- Smoking
- Smoking
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT SMOKE WAS SEEN COMING FROM THEIR CLINITEK STATUS+ INSTRUMENT. THE CUSTOMER WAS UNABLE TO DETERMINE THE EXACT SOURCE OF THE SMOKE. THE CUSTOMER STATED THAT THEY USE THE ORIGINAL POWER SUPPLY. NO BATTERIES, SURGE PROTECTOR OR CONNECT BASE WAS IN USE AT THE TIME OF THE EVENT AND NO SPILLS ON THE INSTRUMENT OCCURRED. THE CUSTOMER HAS POWERED OFF AND UNPLUGGED THE INSTRUMENT. THERE IS NO REPORT OF INJURY OR DAMAGE TO PROPERTY DUE TO THIS EVENT.
Additional Manufacturer Narrative
SIEMENS HAS REQUESTED THE INSTRUMENT AND POWER SUPPLY TO BE RETURNED FOR FURTHER INVESTIGATION AND A REPLACEMENT INSTRUMENT IS BEING SUPPLIED TO THE CUSTOMER. INVESTIGATION WILL COMMENCE ONCE INSTRUMENT HAS BEEN RECEIVED. THE CAUSE OF THIS EVENT IS UNKNOWN.
Additional Manufacturer Narrative
THE INVESTIGATION WAS COMPLETED. A COMPONENT ON THE MAIN BOARD WAS THE SOURCE OF THE BURNT SMELL/SMOKE, BUT IT IS NOT A FIRE RISK. THE D16 COMPONENT CAN FAIL WHEN INCORRECT POWER IS CONNECTED TO THE DEVICE, EITHER THROUGH PLUGGING IN THE WRONG POWER SUPPLY (DEVICE USES A COMMON BARREL CONNECTOR) OR USING 3.5V RECHARGEABLE BATTERIES (DEVICE SPECIFIES USING COMMON 1.5V AA BATTERIES). THIS CAN ALSO BE CAUSED BY ANY NATURAL EVENT WHICH CAUSES A POWER SURGE. THE POWER SUPPLY WAS NOT RETURNED HOWEVER THE CUSTOMER STATED IS WAS THE ONE ORIGINALLY PROVIDED WITH THE SYSTEM AND IT WAS PLUGGED DIRECTLY INTO THE SYSTEM (NO UPS, CONDITIONER, SURGE PROTECTOR, ETC.) THE CAUSE OF THIS EVENT IS UNKNOWN.