MAUDE Adverse Event Report: AGFA N.V. DX-D600 - DXD IMAGING PACKAGE; DX-D 600 SYSTEM

Device Problems Failure to Align (2522); Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/19/2018

Event Type  malfunction  

Manufacturer Narrative

Due to recent changes, agfa (b)(4) is now separate from agfa healthcare (b)(4).Agfa (b)(4) is currently awaiting the assignment of a fda registration number.This report has been submitted via the manufacturer registration number 9616389 for agfa healtcare (b)(4).For this report, the mfr report # 9616389-2018-00017 should be 10058267-2018-00002, however due to technical restraints of the esubmitter system, the agfa (b)(4) owner/operator number could not be entered into the mfr report # field.

Event Description

A customer in the us reported to agfa when using their dx-d 600 system, the tube was moving at an abnormal speed.The customer reported the tube was moving around the room quickly and not lining up with the board.During the investigation by agfa, agfa service confirmed the system was moving at an abnormal speed in the transversal direction.Agfa service replaced the tachometer, which controls the speed of the unit the transversal direction.Agfa service tested the unit and auto centered the unit three times to the wall and table with normal transversal speed movement.The unit is now working as intended.There has been no reported harm to patient or user during these events.

• Brand Name: DX-D600 - DXD IMAGING PACKAGE
• Type of Device: DX-D 600 SYSTEM
• Manufacturer (Section D): AGFA N.V.; septestraat 27; mortsel, B 264 0; BE B 2640
• Manufacturer (Section G): AGFA N.V.; septestraat 27; mortsel, B 264 0; BE B 2640
• Manufacturer Contact: cassandra mcgowan ; 10 s academy street; greenville, SC 29601 ; 8644211984
• MDR Report Key: 8066807
• MDR Text Key: 129028379
• Report Number: 9616389-2018-00017
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• Type of Device Usage: Reuse
• Patient Sequence Number: 1