MAUDE Adverse Event Report: AGFA HEALTHCARE N.V. DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100; DX-D 100 MOBILE

Model Number DX-D100 MOBILE

Device Problems Break (1069); Component Falling (1105); Unintended Collision (1429); Device Slipped (1584); Device Inoperable (1663)

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

Event Date 01/07/2016

Event Type  malfunction  

Event Description

An event of unintended movement of one dx-d100 unit occurred at the site on (b)(6) 2016.The customer from (b)(6) contacted agfa and explained when using the dx-d100 unit the unit side brake did not work and the wheel chain was falling down at that time.The unit hit the wall and this led to the front bumper cover to be broken.It was determined by agfa that if the chain had falling down, the unit brake would not work.Agfa has confirmed a required mandatory upgrade had been performed on this unit in year 2015.Investigation is under way to determine root cause and supplemental reporting will be provided.There has been no reported harm to patient or user during this event.

Manufacturer Narrative

Date of event was corrected from (b)(6) 2016.Catalog # was corrected from 5yq3d to 51a43.Serial # was corrected from (b)(4).

Event Description

(b)(4).The dx-d 100 unit front bumper has been replaced.The unit has been placed back in the production environment and is working as intended.The investigation is still underway to determine the root cause.

Manufacturer Narrative

This supplemental report #2 is being submitted to provide the root cause.The probable root cause was identified by march 15, 2016, during the investigation by agfa and the supplier.When the wheel of the dx-d 100 was installed by the dealer engineer, complete torque was applied to one of the two screws which connects the wheel to the motor.The same force was not applied to both screws, the pinions could not be aligned, and the wheel chain became stressed.The chain fell down due to a jump of the chain in the pinions or a broken tooth of the pinion.Awareness training of this dealer related to the chain will be performed.

• Brand Name: DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100
• Type of Device: DX-D 100 MOBILE
• Manufacturer (Section D): AGFA HEALTHCARE N.V.; septestraat 27; mortsel, belgium B 264 0; BE B 2640
• Manufacturer (Section G): AGFA HEALTHCARE N.V.; septestraat 27; mortsel, belgium B 264 0; BE B 2640
• Manufacturer Contact: cassandra mcgowan ; 10 south academy street; greenville, SC 29601 ; 8644211984
• MDR Report Key: 5433962
• MDR Text Key: 38773074
• Report Number: 9616389-2016-00002
• Device Sequence Number: 1
• Product Code: IZL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K103597
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DX-D100 MOBILE
• Device Catalogue Number: 51A43
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1