MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-04-22 for PROBEAT manufactured by Hitachi, Ltd, Power Systems Company, Hitachi Works.
[5744633]
The following event has occurred at a probeat iii installation in (b)(6). On (b)(6) the operator of the system found that irradiation occurred which was not consistent with the treatment plan and accordingly stopped the irradiation. On (b)(6) the pt was hospitalized for monitoring. On (b)(6) the pt was discharged from the hospital as no adverse effect was detected. No adverse health consequences have been reported to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003993895-2015-00001 |
| MDR Report Key | 4726833 |
| Report Source | 01,05,06 |
| Date Received | 2015-04-22 |
| Date of Report | 2015-04-06 |
| Date of Event | 2015-04-06 |
| Date Mfgr Received | 2015-04-06 |
| Device Manufacturer Date | 2007-12-26 |
| Date Added to Maude | 2015-06-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1840 OLD SPANISH TRAIL |
| Manufacturer City | HOUSTON TX 77054 |
| Manufacturer Country | US |
| Manufacturer Postal | 77054 |
| Manufacturer Phone | 8325085043 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | 3003993895-04/21/2015-00 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROBEAT |
| Generic Name | PROTON BEAM THERAPY SYSTEM |
| Product Code | LHN |
| Date Received | 2015-04-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HITACHI, LTD, POWER SYSTEMS COMPANY, HITACHI WORKS |
| Manufacturer Address | 3-1-1, SAIWAI-CHO, HITACHI-SHI IBARAKI 317-8511 JA 317-8511 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2015-04-22 |