MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-10-03 for SYSMEX SA-10 CR690716 manufactured by Sysmex Ra Co. Ltd..
[88154309]
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.
Patient Sequence No: 1, Text Type: N, H10
[88154310]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000515253-2017-00035 |
| MDR Report Key | 6912896 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-10-03 |
| Date of Report | 2017-10-03 |
| Date of Event | 2017-04-19 |
| Date Mfgr Received | 2017-04-19 |
| Device Manufacturer Date | 2016-07-07 |
| Date Added to Maude | 2017-10-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PETER SHEARSTONE |
| Manufacturer Street | 1850-3 HIROOKANOMURA |
| Manufacturer City | SHIOJIRI, NAGANO IL 399-0702 |
| Manufacturer Country | JA |
| Manufacturer Postal | 399-0702 |
| Manufacturer Phone | 2245439514 |
| Manufacturer G1 | SYSMEX RA CO. LTD. |
| Manufacturer Street | 1850-3 HIROOKANOMURA |
| Manufacturer City | SHIOJIRI, NAGANO 399-0702 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 399-0702 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYSMEX SA-10 |
| Generic Name | SA-10 SAMPLER UNIT |
| Product Code | JRO |
| Date Received | 2017-10-03 |
| Model Number | SA-10 |
| Catalog Number | CR690716 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYSMEX RA CO. LTD. |
| Manufacturer Address | 1850-3 HIROOKA-NOMURA SHIOJIRI-SHI, NAGANO 399-0702 JA 399-0702 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-03 |