MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-09 for PROBEAT manufactured by Hitachi.
[31200499]
Hitachi proton delivery system, under certain conditions e. G. , gantry 180 degrees, is not able to deliver the planned treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5057839 |
| MDR Report Key | 5221823 |
| Date Received | 2015-11-09 |
| Date of Report | 2015-11-09 |
| Date of Event | 2015-11-06 |
| Date Added to Maude | 2015-11-13 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | PROBEAT |
| Generic Name | PROBEAT |
| Product Code | LHN |
| Date Received | 2015-11-09 |
| Model Number | PROBEAT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HITACHI |
| Manufacturer Address | HOUSTON TX 77030 US 77030 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-09 |