SYSMEX SA-10
Received Jun 23, 2017 · Event occurred Feb 27, 2017
Report 1000515253-2017-00026 · MDR key 6665596
Device
Product problems
- Overheating of Device
- Overheating of Device
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
INVESTIGATION BY SYSMEX CORPORATION IN (B)(4) DETERMINED LIGHTNING CAUSED AN EXCESSIVE VOLTAGE THAT EXCEEDED THE PRODUCT STANDARD TO BE APPLIED TO THE POWER SUPPLY UNIT. THE SURGE ABSORBER OF THE BOARD WAS DAMAGED. THERE WAS NO ABNORMALITY FOUND IN THE MANUFACTURING OF THE PRODUCT. THE BOARD WAS REPLACED AND THE INSTRUMENT WAS OPERATIONAL. ANY INCIDENT WITH EXCESSIVE HEAT HAS THE POTENTIAL TO CAUSE USER HARM. THE PCB IS MADE OF FLAME RESISTANT MATERIALS AND COVERED WITH A METAL SHIELD, BUT EXCESSIVE HEAT FROM THE EVENT POSES A RISK OF INHALATION OF SMOKE AND/OR HARMFUL VAPORS FROM MELTED MATERIALS. THE PCB IS NOT ACCESSIBLE TO THE USER, AND IS GROUNDED, REDUCING THE POTENTIAL FOR HARM DUE TO SHOCK.
Description of Event or Problem
THE USER REPORTED SEEING SMOKE EMITTING FROM THE ANALYZER WHILE IN OPERATION AND IMMEDIATELY SHUT OFF THE INSTRUMENT. A SYSMEX FIELD SERVICE ENGINEER WENT ON SITE AND FOUND THE SURGE ABSORBER ON THE PRINTED CIRCUIT BOARD (PCB) POWER SUPPLY WAS CHARRED DUE TO EXCESSIVE HEAT.