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

Model Number DX-D100 MOBILE WIRELESS DR

Device Problems Nonstandard Device (1420); Computer Operating System Problem (2898); Operating System Version or Upgrade Problem (2997); Unintended Movement (3026)

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

Event Date 12/15/2013

Event Type  malfunction  

Event Description

This medial device report is being submitted due to a recent fda inspection held at agfa's (b)(4) location.It was determined that 17 additional occurrences identified with the same event issue as described in mdr report , fda # 9616389-2013-00003, but at different sites, required reporting to document the additional occurrences.This report is for a 17th event in which an agfa field service engineer informed agfa on (b)(6) 2013, that a customer stated their dx-d100 unit was showing signs of unintended movement.The engineer performed the dx-d100 latest version upgrade of the firmware, per a mandatory service bulletin by agfa, and checked the gauges, voltage and encoder connections.The unit did not respond well to the upgrade.Agfa is currently awaiting parts to repair the unit and confirm mandatory service has been performed correctly per the reportable correction reported to the fda on may 15, 2013: fda reference # (b)(4).No harm has been reported for this event.Agfa investigation was already underway for a reportable correction to the fda on may 15, 2013: fda reference # (b)(4).For the corrections, agfa implemented mandatory service bulletins in which all affected units were to be replaced with new firmware and new digital motion control boards.All other documentation for the dx-d100 reportable correction will be reported via fda (b)(4).

• Brand Name: DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100
• Type of Device: DX-D 100 MOBILE WIRELESS
• Manufacturer (Section D): AGFA HEALTHCARE N.V.; septestraat 27; mortsel, belgium B 26 40; BE B 2640
• Manufacturer (Section G): AGFA HEALTHCARE N.V.; septestraat 27; mortsel, belgium B 26 40; BE B 2640
• Manufacturer Contact: deborah huff ; 10 south academy street; greenville, SC 29601 ; 8644211754
• MDR Report Key: 3690260
• MDR Text Key: 21733123
• Report Number: 9616389-2014-00016
• Device Sequence Number: 1
• Product Code: IZL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K103597
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DX-D100 MOBILE WIRELESS DR
• Device Catalogue Number: 5R77U
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1