IMMULITE
Received Nov 24, 2015 · Event occurred Oct 30, 2015
Report 2247117-2015-00063 · MDR key 5248743
Device
Product problems
- Smoking
- Sparking
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) SPECIALIST WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATING THE INSTRUMENT, THE CSE REPLACED THE COMPUTER. THE CAUSE OF SMOKE BEING EMITTED FROM THE INSTRUMENT WAS RELATED TO MALFUNCTION OF THE COMPUTER. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.
Description of Event or Problem
THE OPERATOR ON AN IMMULITE INSTRUMENT REPORTED THAT WHEN THE POWER CORD WAS PLUGGED, THE COMPUTER'S INTERNAL POWER SUPPLY SPARKED AND SMOKED. THE OPERATOR UNPLUGGED THE DEVICE IMMEDIATELY. THERE ARE NO REPORTS OF INJURIES, BURNS OR INHALATION. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE SMOKE EMITTED FROM THE INSTRUMENT.