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 |