DCA VANTAGE PACKED INST USA
Received Sep 22, 2021 · Event occurred Sep 1, 2021
Report 3002637618-2021-00054 · MDR key 12515233
Device
Generic name
Dca Vantage
Manufacturer
Siemens Healthcare DiagnosticsModel number
10282969Catalog number
10282969
Product problems
- Smoking
- Smoking
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SIEMENS HAS COMPLETED THE INVESTIGATION: THE CUSTOMER'S SYSTEM WAS INVESTIGATED AND THE ROOT CAUSE OF THE SMOKE CANNOT BE DETERMINED. THE SYSTEM WAS VISUALLY INSPECTED AND THERE WAS NO EVIDENCE OF DAMAGE. THE PRINTER HEAD WAS CLEAR WITHOUT ANY EVIDENCE OF A JAM. UPON POWERING UP THE SYSTEM, ALL COMPONENTS WERE OPERATIONAL. THE DISPLAY WAS FUNCTIONAL, THE FAN WAS RUNNING, THE MOTOR HOMED TO THE CORRECT LOCATION AND THE HEATER PLATE WAS OPERATIONAL. NO SMOKE OR ODOR WAS OBSERVED. THERE WAS WHAT APPEARED TO BE A DRIED ALCOHOL WIPE WITHIN THE CARTRIDGE COMPARTMENT THAT WAS ALSO DISCOLORED. WHILE IT IS NOT CLEAR WHY THERE WAS A WIPE INSIDE THE CARTRIDGE COMPARTMENT, IT SHOULD BE NOTED THAT OBJECTS SHOULD NOT BE PLACED INSIDE THIS COMPARTMENT UNLESS IT IS A LINT-FREE WIPE FOR REGULAR MAINTENANCE. THE OPERATORS GUIDE DOES NOT INSTRUCT THE USER TO LEAVE ANY CLOTH OR WIPE INSIDE THE SYSTEM WHEN NOT IN USE. THE REASON FOR THE SMOKE OBSERVED BY THE CUSTOMER COULD NOT BE VERIFIED AND THEREFORE THE ISSUE CANNOT BE CONFIRMED AS A SYSTEMIC PRODUCT PROBLEM. THE CUSTOMER SHOULD USE THIS EVENT AS A TRAINING OPPORTUNITY TO ENSURE NO FOREIGN OBJECTS ARE PLACED WITHIN THE CARTRIDGE COMPARTMENT AS IT HAS THE POTENTIAL TO IMPACT THE ANALYZER OPTICS. THE CUSTOMER IS OPERATIONAL WITH A NEW SYSTEM.
Additional Manufacturer Narrative
THE CUSTOMER INDICATED THAT THE ORIGINAL POWER CORD THAT CAME WITH THE INSTRUMENT WAS BEING USED AT THE TIME OF THE EVENT. THE CUSTOMER PLUGS THE INSTRUMENT DIRECTLY INTO THE WALL, NO ADAPTER, BATTERY BACKUP UNIT OR CONDITIONER IS USED. THE OUTLET WAS NOT CAUSING THE SMOKE, NOR WAS IT IMPACTING OTHER DEVICES AFTER THE FACT. THE CUSTOMER WILL RECEIVE A REPLACEMENT SYSTEM AND THE DEFECTIVE ONE WILL BE RETURNED FOR INVESTIGATION. NO INJURY OR DAMAGE TO PROPERTY OCCURRED. THE CAUSE OF THE EVENT IS UNKNOWN.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THEY SAW SMOKE COMING FROM THEIR DCA VANTAGE ANALYZER. THE ANALYZER WAS IMMEDIATELY UNPLUGGED. THERE WAS A STRONG BURNING SMELL PRESENT AT THE POWER CORD. NO FLAMES WERE SEEN, BUT SMOKE WAS VISIBLE. NO SAMPLE WAS BEING RUN AT THAT TIME. THERE WAS NO REPORT OF INJURY TO ANY PATIENT OR OPERATOR DUE TO THIS EVENT.
Remedial action
- Replace