MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-23 for BK-200 503-61750-32 manufactured by Shimadzu Coporation.
[103571173]
When the operator moved the table top plate of bk-200 in the longitudinal direction, the little finger of the right hand holding the edge of the table top board was got caught between the bottom of the top plate and the main body base.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030233-2018-00001 |
| MDR Report Key | 7364895 |
| Date Received | 2018-03-23 |
| Date of Report | 2018-03-14 |
| Date of Event | 2018-02-13 |
| Date Mfgr Received | 2018-02-16 |
| Device Manufacturer Date | 2012-10-23 |
| Date Added to Maude | 2018-03-23 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. TOSHIO KADOWAKI |
| Manufacturer Street | 1, NISHINOKYO, KUWABARA-CHO NAKAGYO-KU |
| Manufacturer City | KYOTO, KYOTO 604-8511 |
| Manufacturer Country | JA |
| Manufacturer Postal | 604-8511 |
| Manufacturer G1 | SHIMADZU CORPORATION |
| Manufacturer Street | 1, NISHINOKYO, KUWABARA-CHO NAKAGYO-KU |
| Manufacturer City | KYOTO, KYOTO 604-8511 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 604-8511 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BK-200 |
| Generic Name | RADIOLOGIC TABLE |
| Product Code | IXQ |
| Date Received | 2018-03-23 |
| Model Number | 503-61750-32 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHIMADZU COPORATION |
| Manufacturer Address | 1, NISHINOKYO KUWABARA-CHO NAKAGYO-KU KYOTO, KYOTO 604-8511 JA 604-8511 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-23 |