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

Device Problem Positioning Problem (3009)

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

Event Date 12/20/2018

Event Type  malfunction  

Manufacturer Narrative

Agfa healthcare nv has recently changed the company structure into two legal entities, named agfa healthcare and agfa nv.This report is for agfa n.V.Agfa n.V's owner operator number is (b)(4).Agfa n.V.Is currently awaiting the assignment of a fda registration number.This report has been submitted via the manufacturer registration number (b)(4) for agfa healtcare n.V.

Event Description

A customer in (b)(6) reported to agfa, while using the dx-d 600 system, they experienced fast downward movement of the tube.The customer reported when the omni-button was pressed, the dx-d 600 system tube moved downward in a fast motion.When the omni-button was released, this immediately stopped the downward fast motion.Agfa service responded and checked the system.Agfa service tested the gas springs and the tension was ok.The balancing was readjusted in the gauge board and the compensation was adjusted.The system was calibrated and tested ok.The root cause is determined to be drifting of the gauge board balancing calibration.The unit is now working as intended and no further incidents have been reported.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: 8245542
• MDR Text Key: 133319030
• Report Number: 9616389-2019-00004
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K112670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/14/2019

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/20/2018
• Initial Date FDA Received: 01/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1