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

Model Number	SOLTUS 450
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation has begun and users are being notified of the problem.
Event or Problem Description
Event description: erratic movement after going down a ramp of 22 degrees.Customer description: 4/10/2023 - slight malfunction this evening.It suddenly started swerving, then backed up on its own really fast and stopped moving all together.I shut it off and turned it back on and it seems to be working fine now.Additionally, another tech reported the portable moving in 360-degree circles on its own on thursday 4/13/23.Actions on going: manufacturer and distributor working in the investigation for finding out the root cause.

• Brand Name: CANON
• 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: 16823113
• Report Number: 9617251-2023-00003
• Device Sequence Number: 7045587
• Product Code: IZL
• UDI-Device Identifier: 08436046002555
• UDI-Public: 08436046002555
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair,Notification
• Type of Report: Initial
• Report Date (Section B): 04/27/2023

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: SOLTUS 450
• Device Catalogue Number: 10451
• 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: 04/19/2023
• Initial Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2022
• 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