MAUDE Adverse Event Report: SEDECAL SEDECAL; MOBILE DIGITAL DIAGNOSTIC X-RAY SYSTEM

Model Number	SEDECAL SOLTUS 500
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	06/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The unit failed to move forward with a red led on the tube head indicating an error, the operator then shutdown and rebooted the system but still encountered the same issue.Two techs attempted to move the portable to get it out of the hallway.The portable all of a sudden engaged but started moving backward at a high rate of speed.The techs let go of the portable and it kept moving and ran over the technologist's foot.The facility indicated that there was no serious injury and made the determination that a voluntary 3500 form was not required.
Additional Manufacturer Narrative
Evaluation has begun and users are being notified of the problem.

• Brand Name: SEDECAL
• Common Device Name: MOBILE DIGITAL DIAGNOSTIC X-RAY SYSTEM
• Manufacturer (Section D): SEDECAL; c/ pelaya, 9,; pol. ind. río de janeiro; algete, madrid 28110 ; SP 28110
• Manufacturer (Section G): SEDECAL SA; pelaya 9; pol. ind. rio de janeiro; algete, madrid 28110 ; SP 28110
• Manufacturer Contact: maria gomez ; pelaya, 9 .; pol. ind. rio de janeiro; algete, madrid 28110 ; SP 28110
• MDR Report Key: 15085406
• Report Number: 9617251-2022-00003
• Device Sequence Number: 19863341
• Product Code: IZL
• UDI-Device Identifier: 08436046002456
• UDI-Public: 08436046002456
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K192936
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification,Repair
• Type of Report: Initial
• Report Date (Section B): 07/21/2022

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: SEDECAL SOLTUS 500
• Device Catalogue Number: 10501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown