MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-06-08 for VOCSN PRT-00490-001 manufactured by Ventec Life Systems, Inc.
| Report Number | 3013095415-2019-00008 |
| MDR Report Key | 8681154 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-06-08 |
| Date of Report | 2019-06-07 |
| Date of Event | 2019-05-08 |
| Date Mfgr Received | 2019-05-08 |
| Device Manufacturer Date | 2018-09-10 |
| Date Added to Maude | 2019-06-08 |
| 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 | MIKE KUBANY |
| Manufacturer Street | 22002 26TH AVE SE |
| Manufacturer City | BOTHELL WA 98021 |
| Manufacturer Country | US |
| Manufacturer Postal | 98021 |
| Manufacturer Phone | 4256861765 |
| Manufacturer G1 | VENTEC LIFE SYSTEMS, INC |
| Manufacturer Street | 22002 26TH AVE SE |
| Manufacturer City | BOTHELL WA 98021 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98021 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VOCSN |
| Generic Name | PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) |
| Product Code | BTA |
| Date Received | 2019-06-08 |
| Returned To Mfg | 2019-05-13 |
| Model Number | PRT-00490-001 |
| Catalog Number | PRT-00490-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VENTEC LIFE SYSTEMS, INC |
| Manufacturer Address | 22002 26TH AVE SE BOTHELL WA 98021 US 98021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-06-08 |