MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-06 for G2 manufactured by Hitachi America, Ltd., Healthcare Division.
[66586438]
Patient Sequence No: 1, Text Type: N, H10
[66586439]
There were alarms and pauses while delivering the treatments fields on g2. The treatment was stopped on g2 and the machine was reviewed for diagnosis and repair. The problem was found to be the switch for the second scatter. The switch was causing the beam to be delivered at an angle rather than flat.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6303571 |
| MDR Report Key | 6303571 |
| Date Received | 2017-02-06 |
| Date of Report | 2017-01-11 |
| Date of Event | 2016-12-06 |
| Report Date | 2016-12-30 |
| Date Reported to FDA | 2016-12-30 |
| Date Reported to Mfgr | 2016-12-30 |
| Date Added to Maude | 2017-02-06 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | G2 |
| Generic Name | SYSTEM, RADIATION THERAPY, CHARGED-PARTICLE, MEDICAL |
| Product Code | LHN |
| Date Received | 2017-02-06 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HITACHI AMERICA, LTD., HEALTHCARE DIVISION |
| Manufacturer Address | 50 PROSPECT AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-06 |