MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-15 for HYBEAT N/A manufactured by Hitachi, Ltd., Healtcare Hitachi Works.
| Report Number | 3003993895-2019-00001 |
| MDR Report Key | 8512837 |
| Date Received | 2019-04-15 |
| Date of Report | 2019-03-18 |
| Date of Event | 2019-02-18 |
| Date Mfgr Received | 2019-02-28 |
| Device Manufacturer Date | 2018-10-15 |
| Date Added to Maude | 2019-04-15 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MIKIMOTO TAKAMATSU |
| Manufacturer Street | 50 PROSPECT AVENUE TARRYTOWN |
| Manufacturer City | NY 105914625 |
| Manufacturer Country | US |
| Manufacturer Postal | 105914625 |
| Manufacturer Phone | 5072618534 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HYBEAT |
| Generic Name | PARTICLE BEAM THERAPY SYSTEM |
| Product Code | LHN |
| Date Received | 2019-04-15 |
| Model Number | HYBEAT |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HITACHI, LTD., HEALTCARE HITACHI WORKS |
| Manufacturer Address | 3-1-1 SAIWAI-CHO HITACHI-SHI, IBARAKI 317-8511 JA 317-8511 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-15 |