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

Model Number	CHALLENGEX AP
Medical Device Problem Codes	Unintended System Motion (1430); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The operator was exposing the arm of the children on the detector placed on the tabletop.But after the last exposure, the operator said the ceiling tubestand can't move.They press several buttons in the console in order to activate the movement.At one moment they grabbed the handle (wheel), and the tube (vertical axis) goes to full speed toward the table top.The operator had time to clear the arm of the children, but his head hit the ceiling tubestand.No injuries were caused.In the meantime the operator said she tried to pull up the wheel without effect, until she released the handle (wheel), and the ceiling tubestand stops 3 cm above tabletop/detector.

• Brand Name: SEDECAL
• Common Device Name: DIGITAL DIAGNOSTIC STATIONARY 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: 17315840
• Report Number: 9617251-2023-00004
• Device Sequence Number: 20362361
• Product Code: KPR
• UDI-Device Identifier: 08436046002388
• UDI-Public: 08436046002388
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K202293
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/12/2023

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: CHALLENGEX AP
• Device Catalogue Number: ChallengeX AP
• 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: 06/23/2023
• Initial Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown