MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2005-09-01 for EUREKA TUBE STAND PM 4000 * manufactured by Continental, C/o Hologic, Inc..
[452576]
X-ray tube stand assembly dislodged from ceiling track when tube was rotated to a 90 degrees. Tube assembly then fell forward off bottom rail assembly striking the x-ray table. No pt was involved in this incident, therefore there was no pt injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221300-2005-00002 |
| MDR Report Key | 672250 |
| Report Source | 00 |
| Date Received | 2005-09-01 |
| Date of Report | 2005-08-22 |
| Date of Event | 2005-07-19 |
| Device Manufacturer Date | 1995-08-01 |
| Date Added to Maude | 2006-02-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | LINDA REED |
| Manufacturer Street | 35 CROSBY DRIVE |
| Manufacturer City | BEDFORD MA 01730 |
| Manufacturer Country | US |
| Manufacturer Postal | 01730 |
| Manufacturer Phone | * |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EUREKA TUBE STAND |
| Generic Name | DIAGNOSTIC X-RAY TUBE MOUNT |
| Product Code | IYB |
| Date Received | 2005-09-01 |
| Model Number | PM 4000 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 661575 |
| Manufacturer | CONTINENTAL, C/O HOLOGIC, INC. |
| Manufacturer Address | * * * |
| Baseline Brand Name | EUREKA TUBE STAND |
| Baseline Generic Name | DIAGNOSTIC X-RAY TUBE MOUNT |
| Baseline Model No | PM 4000 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-09-01 |