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 Sticking (1597); Device Displays Incorrect Message (2591); Unintended Movement (3026)

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

Event Date 11/10/2015

Event Type  malfunction  

Event Description

This medical device report is being submitted due to a 3rd event of unintended movement when using a same dx-d100 mobile unit at a same site as described in 9616389-2015-00055 reported to the fda on 10/29/2015.During the investigation of this third event, the customer reported that the unit can't go more than six inches without alarms going off and wheels locking.The controls and x-ray tube do not operate properly and the unit continues to move on its own.The unit was removed from service on (b)(6) 2015.The supplier (b)(4) will be going onsite with agfa service to further investigate and determine the root cause.There has been no report of harm to user or patient during this event.A supplemental report will follow after investigation results.

• 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 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 watts ; 10 south academy street; greenville, SC 29601 ; 8644211984
• MDR Report Key: 5237174
• MDR Text Key: 31939110
• Report Number: 9616389-2015-00058
• Device Sequence Number: 1
• Product Code: IZL
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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?: Yes
• Date Manufacturer Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2015
• 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