MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-07-13 for * manufactured by Dornier Medtech America, Inc..
[500278]
Patient taken into cysto intubated, positioned, prepped and draped. When ready to make incision, table needed to be moved to position patient under fluoro eye. When this was attempted table locked up and froze in position. This was a case that required fluoro. Case was aborted and patient woke up. Patient was admitted overnight and case was added on to or schedule the next day. This is a consistent problem with this table. The bed locks up constantly and dornier is called for service repeatedly and the problem is never fixed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 742312 |
| MDR Report Key | 742312 |
| Date Received | 2006-07-13 |
| Date of Report | 2006-07-13 |
| Date of Event | 2006-07-11 |
| Report Date | 2006-07-13 |
| Date Reported to FDA | 2006-07-13 |
| Date Added to Maude | 2006-08-01 |
| 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 |
| 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 | * |
| Generic Name | X-RAY, CYSTO, TABLE |
| Product Code | MMZ |
| Date Received | 2006-07-13 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 730146 |
| Manufacturer | DORNIER MEDTECH AMERICA, INC. |
| Manufacturer Address | 1155 ROBERTS BOULEVARD KENNESAW GA 30144 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-07-13 |