MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-01-18 for * 281420MJDXD1 manufactured by Ge Medical Systems, Llc.
[604814]
The control panel of an overhead x-ray unit sparked and began to smoke. The unit was turned off at the breaker. Service was called and the unit was taken out of service. A board shorted out. It was replaced by ge.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 810227 |
| MDR Report Key | 810227 |
| Date Received | 2007-01-18 |
| Date of Report | 2007-01-18 |
| Date of Event | 2007-01-09 |
| Report Date | 2007-01-18 |
| Date Reported to FDA | 2007-01-18 |
| Date Added to Maude | 2007-01-31 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | X-RAY SYSTEM, RADIOGRAPHIC |
| Product Code | IZO |
| Date Received | 2007-01-18 |
| Model Number | 281420MJDXD1 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 797711 |
| Manufacturer | GE MEDICAL SYSTEMS, LLC |
| Manufacturer Address | 3000 N GRANDVIEW BLVD WAUKESHA WI 53188 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-01-18 |