MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-10 for OPTIMA PORTABLE RADIOLOGY MACHINE XR240 manufactured by Ge Medical Systems, Llc.
[178963943]
Chest x-ray performed. Unit had wireless interruptions from detector back to the unit causing loss of image. Wap replaced. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092926 |
| MDR Report Key | 9695078 |
| Date Received | 2020-02-10 |
| Date of Report | 2020-02-06 |
| Date of Event | 2020-01-22 |
| Date Added to Maude | 2020-02-11 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTIMA PORTABLE RADIOLOGY MACHINE |
| Generic Name | SYSTEM, X-RAY, MOBILE |
| Product Code | IZL |
| Date Received | 2020-02-10 |
| Model Number | XR240 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS, LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-10 |