MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-11-18 for IRIX-70 manufactured by Trophy Radiologie.
[560230]
Notified on 11. 01. 04 that the irix 70 x-ray system had a broken cable in the scissor arm. Verified scissor arm had not yet been upgraded, and dates / criteria meet recall requirement. Did not break.
Patient Sequence No: 1, Text Type: D, B5
[7943618]
The reported condition is attributed to a failure of the support arm. This condition was identified by the manufacturer in 1995 and corrective actions were instituted at that time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8020825-2004-00035 |
| MDR Report Key | 810940 |
| Report Source | 05 |
| Date Received | 2004-11-18 |
| Date of Report | 2004-11-11 |
| Date of Event | 2004-10-18 |
| Date Added to Maude | 2007-02-02 |
| 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 | PEGGY BAHT |
| Manufacturer Street | 1765 THE EXCHANGE |
| Manufacturer City | ATLANTA GA 30339 |
| Manufacturer Country | US |
| Manufacturer Postal | 30339 |
| Manufacturer Phone | 6785898556 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1099/1101-5 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IRIX-70 |
| Generic Name | DENTAL X-RAY SYSTEM |
| Product Code | EAP |
| Date Received | 2004-11-18 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 798405 |
| Manufacturer | TROPHY RADIOLOGIE |
| Manufacturer Address | 4 RUE F. PELLOUTIER CROISSY- BEAUBOURG MARNE LA VALLEE CEDEX 2 FR 77437 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-11-18 |