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

Model Number DX-D600

Device Problems Loose or Intermittent Connection (1371); Failure to Align (2522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2018

Event Type  malfunction  

Event Description

On (b)(6) 2018, a customer in (b)(6) reported to agfa that when using their dx-d 600 unit, they experienced a loose bracket.The customer reported the detent marker tilted and caught in the tube carriage, but nothing fell down from the unit.Agfa service responded and confirmed the unit's 110 cm detent marker grub screw was loose and misaligned.Agfa service drilled guide holes and remounted the 110cm, 150cm and 180cm detent markers.No further issues have been reported and the unit is working as intended.There has been no reported harm to patient or user during this event.

• Brand Name: DX-D600 - DXD IMAGING PACKAGE
• Type of Device: DX-D 600 SYSTEM
• Manufacturer (Section D): AGFA HEALTHCARE N.V.; septestraat 27; mortsel antwerpen, belgium B2640 ; BE B2640
• Manufacturer (Section G): AGFA HEALTHCARE N.V.; septestraat 27; mortsel antwerpen, belgium B2640 ; BE B2640
• Manufacturer Contact: cassandra mcgowan ; 10 s academy street; greenville, SC 29601 ; 8644211984
• MDR Report Key: 7374925
• MDR Text Key: 103949891
• Report Number: 9616389-2018-00005
• 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: Health Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 03/27/2018

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
• Device Model Number: DX-D600
• Device Catalogue Number: TYPE 5430/110
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2018
• Initial Date FDA Received: 03/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1