MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2017-03-12 for PROBEAT manufactured by Hitachi, Ltd., Healthcare Hitachi Works.
[69763890]
This device has been installed in only one place in the united states, thus the subject device can be identified. Please note that : the mdr was initially submitted mistakenly to the mdr test system rather than the reporting system on december 30, 2016. After following up with fda to receive further information regarding the status of the mdr, hitachi is re-submitting through the electronic submission system. The company has no additional information since the submission of that mdr on december 30, 2016.
Patient Sequence No: 1, Text Type: N, H10
[69763891]
Beam flatness was degraded due to the displacement of the second scatterer (scc) on (b)(6) 2016. The maximum displacement of the scc has been confirmed to be 5 mm. The degradation of the flatness was measured in the condition scc was displaced, the flatness came to be approximately +/- 5 percent. The working failure of the limit switch and the displacement of the limit switch caused the mis-position of the scc. This event was detected in happening an over travel error on the scc. An over travel error was also observed on (b)(6) 2016, however, the issue for beam flatness was not recognized at that time because the system was back to normal in correcting the limit switch position. The over travel error happened again, the cause and the influence were well investigated on (b)(6) 2016, thus the issue for beam flatness was recognized. Further, the automatic beam position tuning was carried out for the displaced scc and then the scc was relocated to the right position. This situation is similar to that for the displaced scc, thus, the degradation of the flatness also continued up to (b)(6). As well as that, the degradation of the flatness continued up to (b)(6) for the scc displacement happened on (b)(6). As a result, 47 fields in the treatments were performed in the degraded flatness state (b)(6). Regarding the fields per patient, three fields at most for a certain patient were carried out in degraded flatness. In general, a treatment of total 10 to 30 fractions per patient are carried out, and one fraction comprises two or three fields. In the meantime, the degradation of the flatness was approximately +/- 5 percent as stated above. Accordingly, the possibility of the injury is very low, and no injury has been reported to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003993895-2016-00001 |
| MDR Report Key | 6398448 |
| Report Source | OTHER |
| Date Received | 2017-03-12 |
| Date of Report | 2016-12-30 |
| Date of Event | 2016-12-06 |
| Date Mfgr Received | 2016-12-06 |
| Device Manufacturer Date | 2006-03-05 |
| Date Added to Maude | 2017-03-12 |
| 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 |
| Reporter Occupation | SERVICE PERSONNEL |
| 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 NORTH TARRYTOWN |
| Manufacturer City | 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 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROBEAT |
| Generic Name | PROTON BEAM THERAPY SYSTEM |
| Product Code | LHN |
| Date Received | 2017-03-12 |
| 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 | 2017-03-12 |