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

Model Number	SEDECAL X (URS)
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	05/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
This is a diagnostic stationary x-ray system with a digital x-ray receptor panel.The whole tube arm assembly fell off straight arm.Technologist brought patient into room to do a chest study and moved straight arm into first position for chest study and stated the entire tube arm fell off hitting the technologist hand and wrist and then falling to the ground.The patient was not near tubestand at the time of incident so patient did not get injured.Injury: technologist had contusions on her right hand and wrist and was treated at the facility for her injury and then sent home.We should state that his unit has been working in the field for 9 years.If those 8 screws are partially loosened the play and noise coming from the arm when it is being moved should be evident for the technologist much earlier than having falling risk, but the unit, in this deficient state, continued in use till the arm fell down.The cause of this event is improper maintenance.The manufacturer is considering actions for the installed base.

• 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: 14599441
• Report Number: 9617251-2022-00001
• Device Sequence Number: 5077629
• Product Code: KPR
• UDI-Device Identifier: 08436046000933
• UDI-Public: 08436046000933
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K012546
• 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
• Type of Report: Initial
• Report Date (Section B): 05/31/2022

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 X (URS)
• 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: 05/26/2022
• Initial Report FDA Received Date: 06/05/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown