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

Model Number	PROTEUS XR/F ET
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As mentioned in the event's description, the cause of the problem is not related, at all, with a malfunction of the unit but a wrong or defective maintenance task.The assembly instructions for collimator are correct and clear enough and they are included in the system manual as well as in the collimator manual.No further action is required from sedecal side, just to report the event by means of a mdr (3500a form).
Event or Problem Description
The collimator fell off tubehead.The collimator was reattached.There was no injury.The collimator did detach and fall on the table due to a defective reassembly after a service maintenance task as the technologist was positioning the collimator during a patient chest exam, the collimator fell from its mount onto the table.Important information: the collimator was removed the day before to replace tube.The tube was then put back as it was not the cause of the problem.The set screw was not all the way in.Field engineer went to site and screwed the screw back in.

• Brand Name: GE
• Common Device Name: DIGITAL DIAGNOSTIC X-RAY SYSTEM
• Manufacturer (Section D): SEDECAL SA; c/ pelaya, 9 - 13; pol. ind. rio de janeiro; algete, madrid 28110 ; SP 28110
• MDR Report Key: 10520409
• Report Number: 9617251-2020-00002
• Device Sequence Number: 2683023
• Product Code: KPR
• UDI-Device Identifier: 08436046002302
• UDI-Public: 08436046002302
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K042876
• 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 faci
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: PROTEUS XR/F ET
• Device Catalogue Number: SM32991
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1