MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-19 for DCTM manufactured by Del Medical Imaging Corporation.
[28942503]
We initially did not submit a medical device report for this event since we are not the manufacturer/marketer as referenced in 21 cfr 803. 50(a). Recently we have learned that per 21 cfr 803. 22(b)(2) we are required to file a report and therefore we are now submitting this report.
Patient Sequence No: 1, Text Type: N, H10
[28942504]
The x-ray tube and collimator from a overhead tube crane suddenly fell. No injuries were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418964-2015-00002 |
| MDR Report Key | 5159403 |
| Date Received | 2015-10-19 |
| Date of Report | 2015-10-16 |
| Date of Event | 2014-10-22 |
| Date Mfgr Received | 2014-10-22 |
| Device Manufacturer Date | 2005-09-15 |
| Date Added to Maude | 2015-10-19 |
| 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 |
| Reporter Occupation | SERVICE PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR WILLIAM KOSTECKI |
| Manufacturer Street | 241 COVINGTON DRIVE |
| Manufacturer City | BLOOMINGDALE IL 60108 |
| Manufacturer Country | US |
| Manufacturer Postal | 60108 |
| Manufacturer Phone | 8472887022 |
| Manufacturer G1 | DEL MEDICAL IMAGING CORP |
| Manufacturer Street | 11550 WEST KING STREET |
| Manufacturer City | FRANKLIN PARK IL 60131 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60131 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DCTM |
| Generic Name | OVERHEAD TUBE CRANE |
| Product Code | IYB |
| Date Received | 2015-10-19 |
| Model Number | DCTM |
| Operator | RADIOLOGIC TECHNOLOGIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEL MEDICAL IMAGING CORPORATION |
| Manufacturer Address | 11550 WEST KING STREET FRANKLIN PARK IL 60131 US 60131 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-19 |