MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-07-21 for MAVIG 1624520 * manufactured by Ti-ba Enterprises.
[1105376]
During patient prep for a cath lab procedure a staff member was moving the doctor's lead shield away from the patient when the support arm broke off from the vertical connector on the ceiling. One end hit a staff member just above the eye, the other end landed on the rn's lead shield, missing the nurse. The patient was not hit and was unaffected. The support arm was manufactured by mavig but was sold as part of the imaging system. On inspection, it appeared that there was a stress fracture in the mount.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417193 |
| MDR Report Key | 1417193 |
| Date Received | 2009-07-21 |
| Date of Report | 2009-07-21 |
| Date of Event | 2009-06-06 |
| Report Date | 2009-07-21 |
| Date Reported to FDA | 2009-07-21 |
| Date Added to Maude | 2009-07-22 |
| 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 | MAVIG |
| Generic Name | LEAD SHIELD, CEILING MOUNTED |
| Product Code | KPY |
| Date Received | 2009-07-21 |
| Model Number | 1624520 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | N |
| Device Age | 11 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TI-BA ENTERPRISES |
| Manufacturer Address | 25 HYTEC CIRCLE ROCHESTER NY 14606 US 14606 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-07-21 |