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 2019-04-03 for SYSMEX CS-2100I 06372511 manufactured by Sysmex Corporation, I Square.
[140766073]
The sysmex cs-2000i/2100i instructions for use (ifu), chapter 2 - safety information, section 2. 2 - general information warns the user: should the instrument emit any unusual odors or smoke, turn the main switch off immediately and unplug the power cable. Contact your local technical representative. The user appropriately turned off the analyzer, disconnected the power, and contacted siemens healthcare diagnostics. The se replaced the motor block no. 126 assy. Without resolution. The se returned to the customer site and replaced pcb no. 1279, which resolved the issue. The analyzer cover and motor encoder disc are 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 affected parts are covered with a metal sheet and not accessible to the user, reducing potential harm. Sysmex corporation japan (s-corp) requested the parts for investigation.
Patient Sequence No: 1, Text Type: N, H10
[140766074]
A user in (b)(6) reported a burnt odor emanating from the analyzer. The user immediately turned off the analyzer, disconnected the power, and contacted siemens healthcare diagnostics. A siemens service engineer (se) was dispatched the same day and found the cp unit drive of motor block assembly no. 126 was burnt, parts of the motor encoder disc were melted, a fuse on the power supply (wiring cord no. 5391) was blown, and printed circuit board (pcb) no. 1279 was damaged. Smoke was observed; however, no open fire was observed. No users sought medical attention due to the burning odor. No user or patient harm occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000515253-2019-00009 |
| MDR Report Key | 8478205 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-04-03 |
| Date of Report | 2019-08-22 |
| Date of Event | 2019-02-27 |
| Date Mfgr Received | 2019-08-18 |
| Device Manufacturer Date | 2015-04-21 |
| Date Added to Maude | 2019-04-03 |
| 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 CORPORATION, I SQUARE |
| Manufacturer Street | 262-11 MIZUASHI NOGUCHI-CHO |
| Manufacturer City | KAKOGAWA-CITY, HYOGO 675-0019 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 675-0019 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYSMEX CS-2100I |
| Generic Name | AUTOMATED COAGULATION ANALYZER |
| Product Code | JPA |
| Date Received | 2019-04-03 |
| Model Number | CS-2100I |
| Catalog Number | 06372511 |
| 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 CORPORATION, I SQUARE |
| Manufacturer Address | 262-11 MIZUASHI NOGUCHI-CHO KAKOGAWA-CITY, HYOGO 675-0019 JA 675-0019 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-03 |