MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-14 for SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE 05366719 manufactured by Sysmex Corporation.
[137420840]
The sysmex uf-1000i instructions for use (ifu), warns the user: "should the instrument emit any unusual odors or smoke, turn the main switch off immediately and unplug the power cable. Contact sysmex technical representative. Using the instrument any further bears the risk of fire, electrical shock or personal injury". 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 connects the fixed barcode reader to the i/o controller (b)(4). The maximum voltage traveling through the wiring cord is 5v. The low voltage reduces the potential for shock. No user harm incurred. The fse removed the wiring cord and replaced the tubing to resolve the issue. 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 and tubing) was undetermined.
Patient Sequence No: 1, Text Type: N, H10
[137420841]
The user contacted siemens healthcare diagnostics reporting a burning odor emanating from the analyzer. The siemens representative instructed the user to power off and unplug the analyzer. The user reported the burning odor was eliminated after the analyzer was powered off. A siemens field service engineer (fse) was dispatched and found wiring cord 3735 and surrounding tubing was burnt. No smoke or 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 | 1000515253-2019-00007 |
| MDR Report Key | 8341102 |
| Date Received | 2019-02-14 |
| Date of Report | 2019-02-14 |
| Date of Event | 2019-01-12 |
| Date Mfgr Received | 2019-01-16 |
| Device Manufacturer Date | 2014-05-12 |
| Date Added to Maude | 2019-02-14 |
| 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 |
| Manufacturer Street | 314-2 KITANO NOGUCHI-CHO |
| Manufacturer City | KAKOGAWA, HYOGO 675-0011 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 675-0011 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE |
| Generic Name | AUTOMATED URINE PARTICLE ANALYZER |
| Product Code | LKM |
| Date Received | 2019-02-14 |
| Model Number | UF-1000I |
| Catalog Number | 05366719 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYSMEX CORPORATION |
| Manufacturer Address | 314-2 KITANO NOGUCHI-CHO KAKOGAWA, HYOGO 675-0011 JA 675-0011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-14 |