MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-07-05 for CA-560 01338717 manufactured by Sysmex Ra Co. Ltd..
[113304504]
The sysmex ca-560 instructions for use (ifu). Chapter 2 - safety information, 2. 2 - general information, warns the user: "in the event that the instrument emits an abnormal odor or any smoke, turn off its power supply immediately and pull out the power plug from the wall socket". The suspect printer assembly was returned to sysmex corporation (b)(4) (s-corp) for investigation. Investigation regarding root cause determination is ongoing. Any incident with excessive heat has the potential to cause user harm. The internal printer is made of flame resistant materials and covered with a plastic panel but, excessive heat from the event poses a risk of physical harm.
Patient Sequence No: 1, Text Type: N, H10
[113304505]
The user reported a burning plastic odor emanating from the analyzer's internal printer. There was no fire, flames or smoke reported. The user immediately turned the instrument off and there was no report of injury or harm to the user. It was reported that the printer paper had burn marks. A customer service engineer (cse) replaced the suspect printer assembly to resolve the issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000515253-2018-00010 |
| MDR Report Key | 7664571 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-07-05 |
| Date of Report | 2018-10-19 |
| Date of Event | 2018-06-05 |
| Date Mfgr Received | 2018-06-08 |
| Device Manufacturer Date | 2011-12-22 |
| Date Added to Maude | 2018-07-05 |
| 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 | 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. |
| 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 | CA-560 |
| Generic Name | AUTOMATED COAGULATION ANALYZER |
| Product Code | JPA |
| Date Received | 2018-07-05 |
| Model Number | CA-560 |
| Catalog Number | 01338717 |
| Operator | MEDICAL TECHNOLOGIST |
| 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, NAGANO 399-0702 JA 399-0702 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-05 |