IMMULITE
Received Feb 23, 2016 · Event occurred Jan 26, 2016
Report 2247117-2016-00008 · MDR key 5453121
Device
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE CSE WAS AT THE CUSTOMER SITE TO RESOLVE "CAROUSEL TEMPERATURE" ERRORS WHICH SHUT THE SYSTEM DOWN. THE CSE CHECKED THE SYSTEM AND FOUND VOLTAGE FLUCTUATIONS. THE CSE INSTALLED A NEW POWER SUPPLY, VERIFIED ALL VOLTAGES, PRIMED THE SYSTEM AND RAN A WATER TEST. THE CSE ALSO REPLACED THE DILUTER ASSEMBLY. THE CUSTOMER RAN QUALITY CONTROLS, WHICH RESULTED WITHIN ACCEPTABLE RANGE. THE CAUSE OF SMOKE BEING EMITTED FROM THE INSTRUMENT IS UNKNOWN. SIEMENS IS INVESTIGATING THE ISSUE.
Description of Event or Problem
A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) REPORTED THAT SMOKE WAS EMITTED FROM AN IMMULITE INSTRUMENT AFTER PERFORMING TROUBLESHOOTING ON THE SYSTEM AND INSTALLING NEW PARTS. THE CSE CHECKED THE SYSTEM AND FOUND THAT WIRES WERE OVERHEATED. THERE ARE NO REPORTS OF INJURIES, FIRE, BURNS OR INHALATION. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE SMOKE EMITTED FROM THE INSTRUMENT.
Additional Manufacturer Narrative
THE INITIAL MDR 2247117-2016-00008 WAS FILED ON FEBRUARY 23, 2016. ADDITIONAL INFORMATION (01/26/2016): THE OVERHEATED WIRES WERE FOUND IN THE HARNESS FROM THE MOTHER PRINTED CIRCUIT BOARD TO THE DILUTER ASSEMBLY. THE SIEMENS CUSTOMER SERVICE ENGINEER (CSE) REPLACED THE HARNESS TO DILUTER AND THE MOTHER PRINTED CIRCUIT BOARD. SIEMENS IS INVESTIGATING THE ISSUE.
Additional Manufacturer Narrative
THE INITIAL MDR 2247117-2016-00008 WAS FILED ON FEBRUARY 23, 2016. SUPPLEMENTAL MDR 2247117-2016-00008_S1 WAS FILED ON FEBRUARY 23, 2016. ADDITIONAL INFORMATION (01/26/2016): THE CAUSE OF SMOKE BEING EMITTED FROM THE INSTRUMENT WAS OVERHEATING OF WIRE INSULATION. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.