MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-09-17 for MAVIG OT25U50 10KG * manufactured by Ti-ba Enterprises, Inc..
[1184375]
The metal arm and radiology shield broke off from the machine while the machine was being positioned over the patient. The broken part struck the staff person who sustained only minor injuries. This is the third arm that has come off a machine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1488340 |
| MDR Report Key | 1488340 |
| Date Received | 2009-09-17 |
| Date of Report | 2009-09-17 |
| Date of Event | 2009-07-06 |
| Report Date | 2009-09-17 |
| Date Reported to FDA | 2009-09-17 |
| Date Added to Maude | 2009-10-01 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | MAVIG |
| Generic Name | RADIATION SHIELD WITH SUPPORT ARM |
| Product Code | KPY |
| Date Received | 2009-09-17 |
| Model Number | OT25U50 10KG |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4.5 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TI-BA ENTERPRISES, INC. |
| Manufacturer Address | 25 HYTEC CIRCLE ROCHESTER NY 14606 US 14606 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-09-17 |