MAUDE Adverse Event Report: AGFA-GEVAERT HEALTHCARE GMBH DR 600

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/17/2019

Event Type  malfunction  

Event Description

A customer in the (b)(6) reported to (b)(4) the collimator possibly fell from the dr 600 system.The customer states they were not sure exactly what has fallen off the dr 600 system but it sounds like the collimator.Investigation is underway and a supplemental report will be provided.There has been no reported harm to patient or user during these events.There has been no reported harm to patient or users for this event.

Manufacturer Narrative

This final report is being submitted to provide correct details of the incident, the root cause, and actions taken.Agfa service responded and confirmed the details of the incident with the customer.The collimator did not fall from the agfa dr 600 system as previously reported.The collimator flange was somewhat loose and showed some mechanical play.The root cause is confirmed as the collimator system flange became loosened.Agfa service removed the collimator, adjusted and tightened the flange, and refit the the collimator to the dr 600 system.The system was tested and test exposures completed successfully.There has been no reported harm to patient or user during these events.

Event Description

This supplement report #1 is being submitted to provide correct details of the incident, the root cause, and actions taken.

• Brand Name: DR 600
• Type of Device: DR 600
• Manufacturer (Section D): AGFA-GEVAERT HEALTHCARE GMBH; max planck strasse 1; peissenberg, D8238 0; BE D82380
• MDR Report Key: 9207659
• MDR Text Key: 201831590
• Report Number: 9613152-2019-00002
• Device Sequence Number: 1
• Product Code: MQB
• Combination Product (y/n): N
• PMA/PMN Number: K152639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 10/22/2019

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/17/2019
• Initial Date FDA Received: 10/18/2019
• Supplement Dates Manufacturer Received: 10/22/2019
• Supplement Dates FDA Received: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1