CLINITEK STATUS+ USA
Received Dec 15, 2021 · Event occurred Dec 1, 2021
Report 3002637618-2021-00072 · MDR key 13009284
Device
Generic name
Clinitek Status+
Manufacturer
Siemens Healthcare DiagnosticsModel number
10379675Catalog number
10379675
Product problems
- Smoking
- Smoking
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SIEMENS HAS COMPLETED THE INVESTIGATION OF THE CUSTOMER'S RETURNED INSTRUMENT AND POWER SUPPLY. THE INVESTIGATION OF THE RETURNED INSTRUMENT DETERMINED THAT THE CAUSE OF THE ISSUE WAS DUE TO A FAILURE OF THE D16 ON THE MAIN PCB. D16 IS THE OVERVOLTAGE PROTECTOR DIODE, WHICH BLOWS IF THE VOLTAGE APPLIED TO THE INSTRUMENT IS TOO HIGH. THE POWER SUPPLY RETURNED WITH THE INSTRUMENT IS NOT THE SIEMENS POWER SUPPLY.THE CUSTOMER IS OPERATIONAL WITH A REPLACEMENT INSTRUMENT.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THEIR CLINITEK STATUS+ WOULD NOT POWER ON. THEY TRIED ANOTHER POWER ADAPTER AND A NEW OUTLET WITHOUT SUCCESS. AFTER INSERTING BATTERIES, THE INSTRUMENT BECAME VERY HOT AND LIGHT SMOKE STARTED COMING FROM THE PRINTER AREA. AFTER REMOVING THE BATTERIES THE SMOKE STOPPED. THERE IS NO REPORT OF INJURY FROM THIS EVENT.
Additional Manufacturer Narrative
SIEMENS HAS ASKED FOR THE INSTRUMENT TO BE RETURNED FOR INVESTIGATION. NO ONE WAS HARMED BY THIS SMOKING ANALYZER AND NO PROPERTY WAS DAMAGED. THE CUSTOMER IS GETTING A REPLACEMENT SYSTEM. THE CAUSE OF THIS EVENT IS UNKNOWN.
Remedial action
- Replace