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U.S. Department of Health and Human Services

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

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SOCIEDAD ESPAÑOLA DE ELECTROMEDICINA Y CALIDAD S.A RADPRO MOBILE 40KW DIGITAL MOBILE X-RAY SYSTEM Back to Search Results
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.
 
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Brand NameRADPRO MOBILE 40KW DIGITAL MOBILE X-RAY SYSTEM
Type of DeviceRADPRO 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 Key7267939
MDR Text Key100005940
Report Number1064504-2018-00001
Device Sequence Number1
Product Code MQB
UDI-Device Identifier08436046001510
UDI-Public08436046001510
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received02/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Radiologic Technologist
Device Model NumberSM-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 FDA02/14/2018
Distributor Facility Aware Date02/09/2018
Device Age3 YR
Event Location Hospital
Date Report to Manufacturer02/14/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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