MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-03-26 for MOTORIZED X-RAY FILM VIEWER MV 300 * manufactured by S&s X-ray Products, Inc..
[50288]
"indicators: lights out, light flash, burning odor, 1-2 years old. Results: main light power wire burn into. Concerns: delayed viewing of x-rays, fire hazard, electrical shock hazard. " facility has had three of five units experience this problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1011043 |
| MDR Report Key | 78699 |
| Date Received | 1997-03-26 |
| Date of Report | 1997-03-19 |
| Date Added to Maude | 1997-03-28 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MOTORIZED X-RAY FILM VIEWER |
| Generic Name | MOTORIZED X-RAY FILM VIEWER |
| Product Code | IXC |
| Date Received | 1997-03-26 |
| Model Number | MV 300 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 78321 |
| Manufacturer | S&S X-RAY PRODUCTS, INC. |
| Manufacturer Address | 1101 LINWOOD ST BROOKLYN NY 11208 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-03-26 |