MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2004-04-29 for DYNARAD PHANTOM 501031 manufactured by Del Medical Imaging.
[20510932]
Tube head assembly, of a portable x-ray unit, became detached from the arm assembly of the device. This occurred on the first day the unit was placed into service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418964-2004-00002 |
| MDR Report Key | 555758 |
| Report Source | 06 |
| Date Received | 2004-04-29 |
| Date of Report | 2004-03-30 |
| Date of Event | 2004-03-01 |
| Date Mfgr Received | 2004-03-30 |
| Device Manufacturer Date | 2004-02-01 |
| Date Added to Maude | 2004-11-22 |
| 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 | VERONICA MERIDITH |
| Manufacturer Street | 11550 W. KING STREET |
| Manufacturer City | FRANKLIN PARK IL 60131 |
| Manufacturer Country | US |
| Manufacturer Postal | 60131 |
| Manufacturer Phone | * |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DYNARAD |
| Generic Name | PORTABLE X-RAY EQUIPMENT |
| Product Code | IYB |
| Date Received | 2004-04-29 |
| Returned To Mfg | 2004-04-08 |
| Model Number | PHANTOM |
| Catalog Number | 501031 |
| Lot Number | NA |
| ID Number | NA |
| Device Expiration Date | 2004-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 545409 |
| Manufacturer | DEL MEDICAL IMAGING |
| Manufacturer Address | * FRANKLIN PARK IL 60131 US |
| Baseline Brand Name | DYNARAD |
| Baseline Generic Name | PORTABLE X-RAY EQUIPMENT |
| Baseline Model No | PHANTOM |
| Baseline Catalog No | 501031 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-04-29 |