MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-11-16 for SYSMEX CA-1500 99324114 manufactured by Sysmex Ra Co., Ltd. Main Plant.
[129180133]
The ca-1500 system operator's manual, warns the user: "in the event the instrument emits an abnormal odor or any smoke, turn off the power switch immediately and disconnect the power plug from the wall socket. If the instrument is used continuously in this state, there is a potential that fire, electrical shock, or injury may result. Contact your service representative for inspection. " the user appropriately contacted siemens healthcare diagnostics upon noticing the burning odor. The wiring cord is made of flame resistant materials, but excessive heat from a malfunction poses a risk of inhalation of smoke and/or harmful vapors from scorched materials. The wiring cord is not accessible to the user, reducing potential harm. The wiring cord was not available for further investigation. It was determined a short circuit occurred but root cause of the short circuit (damage to the cord, surge, etc. ) was undetermined. The wiring cord connects the printed circuit board (pcb) to the sampler, controlling all components of the sampler. The maximum voltage traveling through the wiring cord is 12v. The low voltage reduces the potential for shock, as the analyzer was operating when the odor was noticed and no user harm incurred. The fse replaced the power supply, pcb, and wiring cord to resolve the issue.
Patient Sequence No: 1, Text Type: N, H10
[129180134]
The user reported a burning odor emanating from the analyzer and the analyzer display turned off and on. The user contacted siemens healthcare diagnostics. A siemens field service engineer (fse) was dispatched and found wiring cord 2462 was burnt. No open fire was observed. No users sought medical attention due to the burning odor. No user or patient harm incurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000515253-2018-00014 |
| MDR Report Key | 8080065 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-11-16 |
| Date of Report | 2018-11-16 |
| Date of Event | 2018-10-09 |
| Date Mfgr Received | 2018-10-19 |
| Device Manufacturer Date | 2013-05-28 |
| Date Added to Maude | 2018-11-16 |
| 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. JASNA FRONTZ |
| Manufacturer Street | 577 APTAKISIC RD |
| Manufacturer City | LINCOLNSHIRE IL 60069 |
| Manufacturer Country | US |
| Manufacturer Postal | 60069 |
| Manufacturer Phone | 2245439753 |
| Manufacturer G1 | SYSMEX RA CO., LTD. MAIN PLANT |
| Manufacturer Street | 1850-3 HIROOKA-NOMURA |
| 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 CA-1500 |
| Generic Name | AUTOMATED COAGULATION ANALYZER |
| Product Code | JPA |
| Date Received | 2018-11-16 |
| Model Number | CA-1500 |
| Catalog Number | 99324114 |
| 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. MAIN PLANT |
| Manufacturer Address | 1850-3 HIROOKA-NOMURA SHIOJIRI, NAGANO 399-0702 JA 399-0702 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-16 |