MAUDE Adverse Event Report: SOCIEDAD ESPAÑOLA DE ELECTROMEDICINA Y CALIDAD S.A RADPRO MOBILE 40KW DIGITAL MOBILE X-RAY SYSTEM

Model Number SM-40HF-B-D-C

Device Problems Mechanical Problem (1384); Unintended Movement (3026)

Patient Problem Pain (1994)

Event Date 02/08/2018

Event Type  malfunction  

Event Description

The following was reported to virtual imaging, inc.By (b)(6) of (b)(6) on (b)(6) 2018: on (b)(6) 2018, (b)(6) (radiographic technologist) was driving a radpro mobile 40 kw digital x-ray system (the "unit") down a hallway by the cafeteria in (b)(6).(b)(6) drove the unit over a metal threshold, and the unit began pulling to the left and driving in a circle.The unit drove onto (b)(6)'s foot and bent his leg inward, causing knee pain.At this time (b)(6) hit the emergency stop button.Upon restarting, the unit was driven back to the main department of (b)(6) without any complications.(b)(6) did not seek medical help.

• Brand Name: RADPRO MOBILE 40KW DIGITAL MOBILE X-RAY SYSTEM
• Type of Device: RADPRO MOBILE 40KW DIGITAL MOBILE X-RAY SYSTEM
• Manufacturer (Section D): SOCIEDAD ESPAÑOLA DE ELECTROMEDICINA Y CALIDAD S.A; pelaya, 9-13,; poligono industrial; rio de janerio, 28110 alegate, madrid ; SP
• MDR Report Key: 7267939
• MDR Text Key: 100005940
• Report Number: 1064504-2018-00001
• Device Sequence Number: 1
• Product Code: MQB
• UDI-Device Identifier: 08436046001510
• UDI-Public: 08436046001510
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Model Number: SM-40HF-B-D-C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/14/2018
• Distributor Facility Aware Date: 02/09/2018
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 58