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

Model Number	SEDECAL SOLTUS 450
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	10/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation has begun and users are being notified of the problem.
Event or Problem Description
Technician mm , radiology technologist, night shift was coming down ramp from hpmc ed to radiology department with canon soltus 450st mobile x-ray unit "k", sn# (b)(4) and it suddenly went into reverse without warning.Marlon was pinned against railing wall and injured hand.The x-ray unit was damaged - the plastic frame under handle in front broke off., radiology technologist, night shift was coming down ramp from hpmc ed to radiology department with canon soltus 450st mobile x-ray unit "k", sn# (b)(4) and it suddenly went into reverse without warning.Mm was pinned against railing wall and injured hand.The x-ray unit was damaged - the plastic frame under handle in front broke off.

• 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: 15986297
• Report Number: 9617251-2022-00006
• Device Sequence Number: 12288052
• Product Code: IZL
• UDI-Device Identifier: 08436046002456
• UDI-Public: 08436046002456
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Notification,Repair
• Type of Report: Initial
• Report Date (Section B): 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SEDECAL SOLTUS 450
• 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: 10/17/2022
• Initial Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2019
• 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