MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-07 for PORTABLE X-RAY MACHINE manufactured by Ge.
[178583407]
Chest x-ray performed. Raw images did not process and fell off the que. The portable lost connection with the wireless detector. Wap and registered detector was changed out. Machine returned to service. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092860 |
| MDR Report Key | 9686730 |
| Date Received | 2020-02-07 |
| Date of Report | 2020-02-05 |
| Date of Event | 2020-01-22 |
| Date Added to Maude | 2020-02-10 |
| 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 | PORTABLE X-RAY MACHINE |
| Generic Name | SYSTEMS, X-RAY, MOBILE |
| Product Code | IZL |
| Date Received | 2020-02-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-07 |