MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-01 for EASYDIAGNOST ELEVA manufactured by .
[144105279]
Fluoroscopy unit stopped working during procedure. Fda safety report id# (b)(4). See scanned pages.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086346 |
| MDR Report Key | 8574013 |
| Date Received | 2019-05-01 |
| Date of Report | 2019-04-29 |
| Date of Event | 2019-04-24 |
| Date Added to Maude | 2019-05-02 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 0 |
| Brand Name | EASYDIAGNOST ELEVA |
| Generic Name | SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE - INTENSIFIED |
| Product Code | JAA |
| Date Received | 2019-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Brand Name | EASYDIAGNOST ELEVA |
| Generic Name | SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE - INTENSIFIED |
| Product Code | JAA |
| Date Received | 2019-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILLIPS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-01 |