MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-12-11 for ICHEM VELOCITY manufactured by Iris International.
[17282611]
Customer reported that the hospital's velocity analyzer that reported no blood pressure a few times and few to moderate rbcs on the iq200 for the same pt. Customer stated that at no time were any erroneous results reported on any pts. No pts received any different treatment due to the false negative report of blood off the velocity analyzer. The presence of wbcs was verified by the iq200.
Patient Sequence No: 1, Text Type: D, B5
[17504075]
No pts were harmed or treated any differently due to this problem. Iris fse reviewed serviced the instrument (i. E. , aligned the probe), reviewed the error log and performed the velocity performance checklist. Upon completion, controls were ran and were within specifications. System was deemed operational without any further issues.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2023446-2013-00043 |
| MDR Report Key | 3636176 |
| Report Source | 05 |
| Date Received | 2013-12-11 |
| Date of Report | 2013-12-11 |
| Date of Event | 2013-09-16 |
| Date Mfgr Received | 2013-09-16 |
| Device Manufacturer Date | 2012-04-01 |
| Date Added to Maude | 2014-03-26 |
| 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 | SUDHA GUPTA |
| Manufacturer Street | 9172 ETON AVE. |
| Manufacturer City | CHATSWORTH CA 91311 |
| Manufacturer Country | US |
| Manufacturer Postal | 91311 |
| Manufacturer Phone | 8185277497 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICHEM VELOCITY |
| Generic Name | ICHEM VELOCITY |
| Product Code | JJW |
| Date Received | 2013-12-11 |
| Model Number | VELOCITY |
| ID Number | 700-7177-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IRIS INTERNATIONAL |
| Manufacturer Address | CHATSWORTH CA 91311 US 91311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-12-11 |