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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
After using the mobile, the mobile light went red as the x-ray technologist was backing out of a patient's room.The x-ray technologist re-docked the tube in an attempt to reset the mobile machine, and headed back to the department with the mobile driving in "turtle" mode and the tube head light showing red.While returning back to the department, mid turn the mobile went full speed uncontrollably in reverse and slammed into the wall.
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: 15085434
• Report Number: 9617251-2022-00002
• Device Sequence Number: 4814316
• Product Code: IZL
• UDI-Device Identifier: 08436046002456
• UDI-Public: 08436046002456
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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