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 2017-06-23 for SYSMEX SA-10 CR690716 manufactured by Sysmex Ra Co. Ltd..
[78468893]
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.
Patient Sequence No: 1, Text Type: N, H10
[78468894]
The user reported a power outage occurred during a thunderstorm. The analyzer power remained on through the use of an uninterrupted power supply (ups). When the user tried to perform sample analysis, the sampler was not functioning. A sysmex field service engineer (fse) went on site and found the surge absorber on the printed circuit board (pcb) power supply was charred due to excessive heat.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000515253-2017-00023 |
| MDR Report Key | 6665588 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-06-23 |
| Date of Report | 2017-06-23 |
| Date of Event | 2017-02-02 |
| Date Mfgr Received | 2017-02-02 |
| Device Manufacturer Date | 2016-06-28 |
| Date Added to Maude | 2017-06-23 |
| 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 | 577 APTAKISIC RD |
| Manufacturer City | LINCOLNSHIRE IL 60069 |
| Manufacturer Country | US |
| Manufacturer Postal | 60069 |
| 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 | 2017-06-23 |
| Model Number | SA-10 |
| Catalog Number | CR690716 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYSMEX RA CO. LTD. |
| Manufacturer Address | 1850-3 HIROOKANOMURA SHIOJIRI, NAGANO 399-0702 JA 399-0702 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-23 |