MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-12-13 for UNK * manufactured by Ti-ba Enterprises, Inc. (mavig Gmbh).
[21716449]
While the patient was being draped for the procedure, the x-ray arm broke and fell off from the ceiling suspension system striking the cath lab tech on the shoulder. The tech had lifted the shield part of the x-ray arm up when the upper part of the arm broke falling to the ground. The patient was not struck by the arm nor were they injured in any way. This was the fourth occurrence of this type experienced by facility. Mavigg replaced all ceiling suspension systems in this facility in september, 2005 with a steel version of the product and there have been no additional incidents since the equipment was replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 668099 |
| MDR Report Key | 668099 |
| Date Received | 2005-12-13 |
| Date of Report | 2005-12-13 |
| Date of Event | 2005-08-19 |
| Report Date | 2005-12-13 |
| Date Reported to FDA | 2005-12-13 |
| Date Added to Maude | 2006-01-28 |
| 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 | UNK |
| Generic Name | CEILING SUSPENSION SYSTEM |
| Product Code | IYB |
| Date Received | 2005-12-13 |
| Returned To Mfg | 2005-09-01 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 657467 |
| Manufacturer | TI-BA ENTERPRISES, INC. (MAVIG GMBH) |
| Manufacturer Address | 25 HYTEC CIRCLE ROCHESTER NY 14606 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-12-13 | |
| 2 | 0 | 2005-12-13 |