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

Model Number DX-D600

Device Problem Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2017

Event Type  malfunction  

Event Description

This medial device report is being submitted due to an additional similar issue that was originally reported in fda mdr report: 9616389-2016-00003.On january 20, 2017, agfa became aware of an event in which the customer experienced a bolt or a similar component falling down from the longitudinal detent of the dx-d 600 unit.The unit has been removed from service and investigation is under way to determine the root cause.A supplemental report will be provided.There has been no reported harm to patient or user during this event.Potentially unsecured mechanical detent marker of dx-d600s has already been communicated for a reportable correction to the fda: fda reference # 9616389-05-03-2016-002-c.

Manufacturer Narrative

The root cause was identified by february 14, 2017 during the investigation by agfa and the supplier.Although it has been reported that a bolt fell down from the detent of the dx-d 600, it has been concluded this is an isolated case.The dx-d 600 detent assembly was replaced.The unit is now working as intended.There has been no reported harm to patient or user during this event.

Event Description

This supplement report #1 is being submitted to provide the root cause.

• Brand Name: DX-D600 - DXD IMAGING PACKAGE
• Type of Device: DX-D 600 SYSTEM
• 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: 6292413
• MDR Text Key: 66480091
• Report Number: 9616389-2017-00001
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K112670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 03/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DX-D600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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