MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-11 for PROBEAT-V manufactured by Hitachi, Ltd., Healthcare Hitachi Works.
[70017827]
A parameter in the positioning image analysis system (pias) for isocenter position #1 in treatment room 2 was mistakenly changed during the software modification work on (b)(6) 2016. A service and maintenance engineer discovered the mis-setting of the parameter on (b)(6) 2017, and it was corrected immediately. According to the treatment record after (b)(6) 2016, one patient was found to receive treatments around the shoulder at isocenter position #1. The fourteen fractions out of twenty-five were applied to the patient under the faulty condition starting from (b)(6) 2016. The incorrect parameter could have affected the patient positioning accuracy. As a result of investigation, the amount of deviation is estimated in the range of 0. 24cm to 1. 36cm, varying by each fraction. No adverse event for the patient has been reported. This issue has been resolved and the system is currently working correctly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003993895-2017-00001 |
| MDR Report Key | 6398200 |
| Date Received | 2017-03-11 |
| Date of Report | 2017-03-11 |
| Date of Event | 2017-02-10 |
| Date Mfgr Received | 2017-02-10 |
| Device Manufacturer Date | 2016-01-27 |
| Date Added to Maude | 2017-03-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MR. MIKIMOTO TAKAMATSU |
| Manufacturer Street | 50 PROSPECT AVE |
| Manufacturer City | NORTH TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145246636 |
| Manufacturer G1 | HITACHI, LTD., HEALTHCARE HITACHI WORKS |
| Manufacturer Street | 3-1-1 SAIWAI-CHO |
| Manufacturer City | HITACHI-SHI, IBARAKI 317-8511 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 317-8511 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PROBEAT-V |
| Generic Name | PROTON BEAM THERAPY SYSTEM |
| Product Code | LHN |
| Date Received | 2017-03-11 |
| Model Number | PROBEAT-V |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HITACHI, LTD., HEALTHCARE HITACHI WORKS |
| Manufacturer Address | 3-1-1 SAIWAI-CHO HITACHI-SHI, IBARAKI 317-8511 JA 317-8511 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-11 |