MAUDE Adverse Event Report: SHIMADZU COPORATION BK-200; RADIOLOGIC TABLE

Model Number 503-61750-32

Device Problem Structural Problem (2506)

Patient Problem Injury (2348)

Event Date 02/13/2018

Event Type  malfunction  

Event Description

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.

• Brand Name: BK-200
• Type of Device: RADIOLOGIC TABLE
• Manufacturer (Section D): SHIMADZU COPORATION; 1, nishinokyo kuwabara-cho; nakagyo-ku; kyoto, kyoto 604-8 511; JA 604-8511
• Manufacturer (Section G): SHIMADZU CORPORATION; 1, nishinokyo, kuwabara-cho; nakagyo-ku; kyoto, kyoto 604-8 511; JA 604-8511
• Manufacturer Contact: toshio kadowaki ; 1, nishinokyo, kuwabara-cho; nakagyo-ku; kyoto, kyoto 604-8-511 ; JA 604-8511
• MDR Report Key: 7364895
• MDR Text Key: 103571173
• Report Number: 8030233-2018-00001
• Device Sequence Number: 1
• Product Code: IXQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 503-61750-32
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/16/2018
• Initial Date FDA Received: 03/23/2018
• Date Device Manufactured: 10/23/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 40 YR