MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-04-06 for ICHEM VELOCITY 700-7177-001 manufactured by Iris International.
[5818427]
Customer stated the controls are failing.
Patient Sequence No: 1, Text Type: D, B5
[13298925]
Customer reported the ichem velocity failing controls. There were no reports of patient results being affected and no reports of change to patient management as a result. An iris field service engineer (fse) replaced and performed an alignment. The fse ran qc which passed. System was operational.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2023446-2015-00116 |
| MDR Report Key | 4782118 |
| Report Source | 05,06 |
| Date Received | 2015-04-06 |
| Date of Report | 2015-03-09 |
| Date of Event | 2015-03-07 |
| Date Mfgr Received | 2015-03-09 |
| Device Manufacturer Date | 2013-03-01 |
| Date Added to Maude | 2015-06-17 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | GOPAL MOHANTY |
| Manufacturer Street | 9172 ETON AVE. |
| Manufacturer City | CHATSWORTH CA 91311 |
| Manufacturer Country | US |
| Manufacturer Postal | 91311 |
| Manufacturer Phone | 8185277379 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICHEM VELOCITY |
| Generic Name | AUTOMATED URINE CHEMISTRY ANALYZER |
| Product Code | CDM |
| Date Received | 2015-04-06 |
| Catalog Number | 700-7177-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IRIS INTERNATIONAL |
| Manufacturer Address | 9172 ETON AVE. CHATSWORTH CA 91311 US 91311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-06 |