MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07,08 report with the FDA on 2006-11-27 for RALCO COLLIMATOR IN XPLORER 1590 SYSTEM R 302 * manufactured by Ralco Inc.
[544336]
A collimator attached to a ceiling mounted x-ray tube assembly came loose while adjusting by the technologist. The technologist caught the unit before it fell on to the table. No patient involved in the incident. The ralco r 302 collimator was attached to the ceiling mounted tube assembly as an integrated component of the xplorer 1590 system. Imaging dynamics initially determined that this is not a reportable event due to the isolated nature of the incident as well as the fact that it was a faulty installation by the dealer. The hospital indicated that they have submitted a mdr report to fda on this incident. However, imaging dynamics could not verify their submission and decided to send this report after discussion with fda inspector who inspected imaging dynamics in 2006.
Patient Sequence No: 1, Text Type: D, B5
[7983283]
The ralco r392 collimator was returned to imaging dynamics for initial evaluation. Imaging dynamics determined that this was an isolated installation error and not a malfunction of the device. The collimator was replaced with a different collimator as per customer's request. The error with the installation was communicated to the imaging dynamic's dealer for their corrective / preventive action. There was no requirement to inform the manufacturer since the product manual has very clear instructions on installation. Imaging dynamics initially determined that this is not a reportable event due to the isolated nature of the incident as well as the fact that it was a faulty installation by the dealer. The hospital indicated that they have submitted a mdr report to fda on this incident. However, imaging dynamics could not verify their submission and decided to send this report after discussion with fda inspector who inspected imaging dynamics in 2006.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616853-2006-00003 |
| MDR Report Key | 792372 |
| Report Source | 06,07,08 |
| Date Received | 2006-11-27 |
| Date of Report | 2006-11-24 |
| Date of Event | 2006-07-20 |
| Date Mfgr Received | 2006-09-27 |
| Date Added to Maude | 2006-12-12 |
| 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 Street | 2340 PEGASUS WAY NE SUITE 15 |
| Manufacturer City | CALGARY, AB T2E 8M5 |
| Manufacturer Country | CA |
| Manufacturer Postal | T2E 8M5 |
| Manufacturer Phone | ** |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RALCO COLLIMATOR IN XPLORER 1590 SYSTEM |
| Generic Name | COLLIMATOR |
| Product Code | IZW |
| Date Received | 2006-11-27 |
| Model Number | R 302 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 780012 |
| Manufacturer | RALCO INC |
| Manufacturer Address | * * * |
| Baseline Brand Name | RALCO COLLIMATOR IN XPLORER 1590 SYSTEM |
| Baseline Generic Name | COLLIMATOR |
| Baseline Model No | R 302 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-11-27 |