MAUDE Adverse Event Report: SEDECAL SA SEDECAL; DIAGNOSTIC X-RAY OVERHEAD TUBE STAND

Model Number	NOVA FA
Medical Device Problem Codes	Unintended System Motion (1430); Device Issue (2379)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The two cables and pulley were taken to sedecal the same morning of may 25th for a deeper analysis.The rest of the damaged equipment, once removed, was taken to sedecal facilities for further investigation.On monday may 28th, we proceeded to assemble the pulley removed in a similar equipment existing at sedecal facilities.When operating the equipment in such conditions, an unusual noise was detected in the vertical movement.Once the cause of this was analyzed, it was found that the noise was due to friction between the two steel cables, which had come into contact due to the greater wear produced in one of the grooves of the pulley in question we will communicate to all customers a mandatory review of the entire installed base by the various technical services to verify the status of this pulley and the two steel cables, proceeding to change them in case of detecting any deterioration in the cables or irregular or excessive wear of the pulley.
Event or Problem Description
This incident involves a malfunction in a diagnostic x-ray system, specifically the overhead tube crane.This is a ceiling mounted device which holds the x-ray tube and the collimator.This assembly can be moved both horizontally and vertically.In this case, the assembly fell to the ground without any command from the operator to do this.Had there been a person underneath the tube crane at the time, that person could have been severely injured or killed because of the mass involved.

• Brand Name: SEDECAL
• Common Device Name: DIAGNOSTIC X-RAY OVERHEAD TUBE STAND
• Manufacturer (Section D): SEDECAL SA; pelaya, 9 .; pol. ind. rio de janeiro; algete, madrid 28110 ; SP 28110
• MDR Report Key: 7633941
• Report Number: 9617251-2018-00001
• Device Sequence Number: 1529648
• Product Code: IYB
• UDI-Device Identifier: 08436046001930
• UDI-Public: 08436046001930
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K133782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 06/21/2018

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: NOVA FA
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 06/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1