SYSMEX SA-10
Received Oct 3, 2017 · Event occurred Apr 19, 2017
Report 1000515253-2017-00035 · MDR key 6912896
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 EXCESSIVE VOLTAGE THAT EXCEEDED THE PRODUCT STANDARD WAS 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 THAT AFTER A POWER INTERRUPTION, THE SAMPLER WOULD NOT TURN BACK ON. THERE WAS NO VISIBLE FIRE, SMOKE OR ODOR NOTED BY THE USER.