MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD10/10; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 722005

Device Problem Defective Component (2292)

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

Event Type  malfunction  

Manufacturer Narrative

When the investigation has been completed philips will inform the fda.

Event Description

It has been reported to philips that during a clinical procedure, the shutter of the collimator was slightly visible in the field of view of the x-ray image.Upon initial investigation, it became apparent that the maximus rotalix ceramic tube of the x-ray system was leaning.No harm has been reported to philips.Philips has started an investigation for this complaint.

Manufacturer Narrative

Philips has investigated this complaint.The reported incident did not affect the procedure and the customer was able to complete the procedure successfully.Philips has inspected the system on site and confirmed that the shutter was visible in the field of view.The x-ray tube was coming loose from the mounting plate.The x-ray tube did not fall.The involved x-ray tube was removed from the lateral channel.The customer decided not to replace it and to keep the system in use by only using the frontal channel.Philips has opened an investigation as a follow up for the noted complaint.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: ALLURA XPER FD10/10
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; p.o. box 10.000; best 5680 DA; NL 5680 DA
• MDR Report Key: 9145086
• MDR Text Key: 175737258
• Report Number: 3003768277-2019-00075
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• PMA/PMN Number: K041949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/05/2019

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
• Device Model Number: 722005
• Device Catalogue Number: 722005
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/05/2019
• Initial Date FDA Received: 10/02/2019
• Supplement Dates Manufacturer Received: 09/05/2019
• Supplement Dates FDA Received: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1