MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-06-26 for SUMMIT SWIVEL COLLIMATOR D800 manufactured by Summit Industries, Inc..
[19489278]
End user called summit dealer to address "cut-off" on images. Dealer svc rep went to end user facility and found collimator hanging by 2 screws instead of 4, told site to discontinue use. Subject collimator swivel mounting assembly was replaced and returned to manufacturer, summit industries, inc. For evaluation. This incident is related to mfr report# 1450503-2007-00001.
Patient Sequence No: 1, Text Type: D, B5
[19744552]
This incident is related to mfr report# 1450503-2007-00001.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1450503-2007-00002 |
| MDR Report Key | 871844 |
| Report Source | 07 |
| Date Received | 2007-06-26 |
| Date of Report | 2007-06-08 |
| Date of Event | 2007-06-08 |
| Date Facility Aware | 2007-06-08 |
| Report Date | 2007-06-22 |
| Date Mfgr Received | 2007-06-14 |
| Device Manufacturer Date | 1993-11-01 |
| Date Added to Maude | 2007-07-05 |
| 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 | 3 |
| Manufacturer Contact | DON MATSON |
| Manufacturer Street | 2901 WEST LAWRENCE AVENUE |
| Manufacturer City | CHICAGO IL 60625 |
| Manufacturer Country | US |
| Manufacturer Postal | 60625 |
| Manufacturer Phone | 7733534032 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUMMIT SWIVEL COLLIMATOR |
| Generic Name | BEAM LIMITING DEVICE |
| Product Code | IZX |
| Date Received | 2007-06-26 |
| Returned To Mfg | 2007-06-14 |
| Model Number | D800 |
| Lot Number | NA851-1193 |
| Operator | OTHER |
| Device Availability | R |
| Device Age | 12.5 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 854237 |
| Manufacturer | SUMMIT INDUSTRIES, INC. |
| Manufacturer Address | CHICAGO IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-06-26 |