MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-02 for CA-1500 99324114 manufactured by Sysmex Ra Co. Ltd..
[181657703]
A siemens customer service engineer (cse) was dispatched and found a burnt wire. The cse observed the wire was pinched by the chassis of the analyzer between sheet metal components. The chassis of the analyzer is grounded to earth. The cse removed the suspect wire from the affected wiring cord 2513 to resolve the issue. The function and safety of the analyzer is not affected by removing this wire. The other wires in the wiring cord were undamaged. The suspect wire has no function in the ca-1500, but has 12 volts of direct current (vdc) applied. 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 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 shut down the analyzer and contacted siemens healthcare diagnostics. The wiring cord was not available for further investigation. Sysmex corporation (b)(4) (s-corp) reviewed the data and confirmed this to be an isolated event. No systemic analyzer deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
[181657704]
The user observed smoke emanating from the analyzer when attempting to clear a jam in the cuvette hopper. The user immediately shut down the analyzer. There was no report of harm to the user or negative impact to patient care.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000515253-2020-00008 |
| MDR Report Key | 9776930 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-02 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-02-17 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2015-05-15 |
| Date Added to Maude | 2020-03-02 |
| 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 | CA-1500 |
| Generic Name | CA-1500 AUTOMATED COAGULATION ANALYZER |
| Product Code | JPA |
| Date Received | 2020-03-02 |
| 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. |
| Manufacturer Address | 1850-3 HIROOKANOMURA SHIOJIRI, NAGANO 399-0702 JA 399-0702 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-02 |