MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2009-07-16 for AMVEX FI-C15UO-DD manufactured by Amvex.
[1180026]
(b)(4): the unit will not shut off at "zero" position. The complaint did not report that there was any adverse consequences for pts.
Patient Sequence No: 1, Text Type: D, B5
[8365610]
Add'l sn #(b)(4). The flometers leaked at "closed" position due to manufacture assembly error. Amvex has initiated a recall the suspected units.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9617620-2009-01029 |
| MDR Report Key | 1488187 |
| Report Source | 99 |
| Date Received | 2009-07-16 |
| Date of Report | 2009-04-07 |
| Device Manufacturer Date | 2007-07-01 |
| Date Added to Maude | 2012-11-02 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 25B EAST PEARCE STREET |
| Manufacturer City | RICHMOND HILL, ONTARIO L4B2M9 |
| Manufacturer Country | CA |
| Manufacturer Postal | L4B2M9 |
| Manufacturer Phone | 9057647736 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMVEX |
| Generic Name | INTEGRATED FLOWMETER |
| Product Code | CAX |
| Date Received | 2009-07-16 |
| Returned To Mfg | 2009-04-14 |
| Model Number | FI-C15UO-DD |
| ID Number | FIA05219CG |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMVEX |
| Manufacturer Address | 25B EAST PEARCE STREET RICHMOND HILL, ONTARIO L4B2M9 CA L4B2M9 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-07-16 |