MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-06-17 for SUMMIT COLLIMATOR D800 MATCH 200 manufactured by Summit Industries.
[4598580]
Facility informed us (service provider) that the collimator came loose and fell striking a pt in the leg while on the x-ray table. We repaired collimator for further use. Condition of pt is unk. We (service provider), were called in to come fix the issue when we were told about the collimator striking a pt. We were not the current service provider of the medical x-ray equipment. Our service engineer remembered the recall from 2007 and repaired according to the recall instructions. Original recall dated 8/3/2007. This report provided by: (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3929691 |
| MDR Report Key | 3929691 |
| Date Received | 2014-06-17 |
| Date of Report | 2014-06-09 |
| Date of Event | 2014-06-05 |
| Date Facility Aware | 2014-06-05 |
| Report Date | 2014-06-09 |
| Date Added to Maude | 2014-07-14 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUMMIT COLLIMATOR |
| Generic Name | D800 COLLIMATOR |
| Product Code | KPW |
| Date Received | 2014-06-17 |
| Model Number | D800 |
| Catalog Number | MATCH 200 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUMMIT INDUSTRIES |
| Manufacturer Address | 2901 W LAWRENCE AVE CHICAGO IL 60625 US 60625 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-06-17 |