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 2020-02-12 for SYSMEX TS-10 BN168792 manufactured by Sysmex Ra Co. Ltd..
[179138176]
The ts-10 instructions for use warn the user in chapter 2 - safety information, section 2. 1 - general information: "in the unlikely event that the system emits an unusual odor or smoke, immediately turn off the main switch and unplug the power cable. Then contact your sysmex service representative. Continued use of the system in such conditions could result in fire, electrical shock or personal injury. " the ts-10 was turned off by the user. Fuses are located in fuse holders at the back of the system behind a metal plate, not readily accessible to the user. Furthermore, the fuse holders are made of flame resistant material, reducing potential for combustion. Investigation by sysmex corporation (b)(4) (s-corp) is in process.
Patient Sequence No: 1, Text Type: N, H10
[179138177]
During normal operation, a user in (b)(6) noted an odor emanating from the tube sorter. A service engineer was dispatched and found one fuse holder to be burned. Replacement of the affected fuse holder and fuse resolved the issue for the user. There was no report of harm to the operator or negative impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000515253-2020-00005 |
| MDR Report Key | 9702399 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-12 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-01-13 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2017-05-12 |
| Date Added to Maude | 2020-02-12 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. NANCY GOULD |
| Manufacturer Street | 577 APTAKISIC RD |
| Manufacturer City | LINCOLNSHIRE, IL |
| Manufacturer Country | US |
| Manufacturer Phone | 5439678 |
| 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 TS-10 |
| Generic Name | AUTOMATED TUBE SORTER |
| Product Code | LXG |
| Date Received | 2020-02-12 |
| Model Number | TS-10 |
| Catalog Number | BN168792 |
| 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 HIROOKANOMURA SHIOJIRI, NAGANO 399-0702 JA 399-0702 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-12 |