MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-03-14 for VEINVIEWER MODEL GS, VERSION 1.1 * manufactured by Christie Medical.
[21407955]
User report: "i was using the vein finder to find a vein. I pushed it away to move around. I reached to pull the vein finder closer by it's arm, and the entire unit tipped over. I moved under it to catch it. I caught it with my right neck, shoulder. If i had not have caught it, it would have crushed the (b)(6) infant on the bed. Understandably, the family was disturbed. I was disturbed. Charge nurse was also at bedside and helped to calm the parents. "during evaluation of the unit, it was found that if the arm is fully extended to the side and the casters are swiveled in the unfavorable orientation, the unit is very easy to tip over.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020194 |
| MDR Report Key | 2020194 |
| Date Received | 2011-03-14 |
| Date of Report | 2011-03-14 |
| Date of Event | 2011-03-05 |
| Report Date | 2011-03-14 |
| Date Reported to FDA | 2011-03-14 |
| Date Added to Maude | 2011-03-16 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VEINVIEWER |
| Generic Name | VEIN VIEWER |
| Product Code | KZA |
| Date Received | 2011-03-14 |
| Model Number | MODEL GS, VERSION 1.1 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHRISTIE MEDICAL |
| Manufacturer Address | 1256 UNION AVENUE MEMPHIS TN 38104 US 38104 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-14 |