MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-09-21 for MAVIG OT25U50 manufactured by Mavig.
[2196640]
Mavig articulating arm model ot25u50 serial number (b)(4) broke during a cardiac catheterization. The lead shield mounted on the articulating arm fell to the floor at the side of the table narrowly missing the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5022356 |
| MDR Report Key | 2265591 |
| Date Received | 2011-09-21 |
| Date of Report | 2011-09-21 |
| Date of Event | 2011-09-21 |
| Date Added to Maude | 2011-09-28 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAVIG |
| Generic Name | MAVIG ARTICULATING ARM |
| Product Code | KPY |
| Date Received | 2011-09-21 |
| Model Number | OT25U50 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAVIG |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-09-21 |