MAUDE Adverse Event Report: SEDECAL, INC RADPRO MOBILE 40KW FLEX PLUS

Model Number	SM-40HF-B-D-VIR
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/04/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported to (b)(4) by (b)(6): the technologist was driving the radpro mobile 40kw flex plus (the "mobile") off the elevator when the mobile unit started moving forward and hit another technologist, then ran into the elevator before stopping.Mr.(b)(6) further reported that the technologist then reported smelling an electrical burning coming from the mobile.The injured technologist then reported to the (b)(6) employee health department to report the incident and injury.The statements above are not deemed to be an admission by (b)(4).

• Brand Name: RADPRO MOBILE 40KW FLEX PLUS
• Common Device Name: RADPRO MOBILE 40KW FLEX PLUS
• Manufacturer (Section D): SEDECAL, INC; c/ pelaya, 9 -13, pol. ind.; rio de janerio, 28110 alegete; madrid,, ; SP
• MDR Report Key: 6814241
• Report Number: 1064504-2017-00002
• Device Sequence Number: 137820
• Product Code: MQB
• UDI-Device Identifier: 08436046002166
• UDI-Public: 08436046002166
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/17/2017
• Report Date (Section F): 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SM-40HF-B-D-VIR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/05/2017
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 07/17/2017