MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-29 for ACCUVEIN HF470 manufactured by Accuvein Inc.
[118554877]
There are several weak points in this roll stand arm system where it can and has broke at different pivot points. This is a design failure issue. There is also a stopper in place so that the arm will not turn 360 degrees, but that stopper has broken in the past and caused the wiring to rip. Manufacturer response for roll stand, accuvein (per site reporter). They just offer to sell us a replacement as they consider these types of failures user abuse issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7825999 |
| MDR Report Key | 7825999 |
| Date Received | 2018-08-29 |
| Date of Report | 2018-08-27 |
| Date of Event | 2018-08-27 |
| Report Date | 2018-08-27 |
| Date Reported to FDA | 2018-08-27 |
| Date Reported to Mfgr | 2018-08-29 |
| Date Added to Maude | 2018-08-29 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCUVEIN |
| Generic Name | DEVICE, VEIN LOCATION, LIQUID CRYSTAL |
| Product Code | KZA |
| Date Received | 2018-08-29 |
| Model Number | HF470 |
| Catalog Number | HF470 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCUVEIN INC |
| Manufacturer Address | 40 GOOSE HILL ROAD COLD SPRING HARBOR NY 11724 US 11724 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-29 |