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	06/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6)2022 at approximately 10:50 am the tech was finishing taking x-rays in a patient room on the 4th floor.While she was attempting to back the portable out of the room she began having difficulty with the portable jerking.She noticed a flashing red light at the time.Once she got the portable out of the room the tube head light was still flashing red.She cycled power to the portable and she was still getting the flashing red light.When attempting to take the portable back to the imaging department the soltus motors were not engaging and moving forward.The tech had to use her strength to push the portable down a hall 20 feet before making a right turn and continuing about another 15 feet before the portable started backing up on its own.The tech said the speed at which the portable was going backwards increased at which time she let go of the handle and the portable began spinning while going in reverse.Its motion was only stopped when hitting a concrete pillar in the hospital hallway.The biomed was then called.When he arrived he activated the e-stop and removed the wheel bolts that connect the wheels to the motors.He then pushed the portable out of the hallway.
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: 15085416
• Report Number: 9617251-2022-00004
• Device Sequence Number: 11792123
• 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): Unknown
• 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): 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