MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-30 for VC10 PUMP, 115V VC-10 manufactured by Gyrus Acmi, Inc.
[104029055]
The device was not returned to olympus for evaluation. The exact cause of the reported event cannot be determined at this time. In addition, limited information regarding the reported patient, procedure and device was provided by the user facility. However, if additional information becomes available or if the device is returned to olympus for evaluation, this report will be supplemented accordingly.
Patient Sequence No: 1, Text Type: N, H10
[104029056]
Olympus was informed during an unspecified procedure, the user facility reported they noticed the patient lost a lot of blood which then got into the over flow canisters of the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00227 |
| MDR Report Key | 7387054 |
| Date Received | 2018-03-30 |
| Date of Report | 2018-03-30 |
| Date of Event | 2018-03-09 |
| Date Mfgr Received | 2018-03-09 |
| Date Added to Maude | 2018-03-30 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 408935-512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VC10 PUMP, 115V |
| Generic Name | VC10 PUMP |
| Product Code | HHI |
| Date Received | 2018-03-30 |
| Model Number | VC-10 |
| Catalog Number | VC-10 |
| Lot Number | N/A |
| ID Number | UDI |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-30 |