MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD20; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 722028

Device Problem Unintended Movement (3026)

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

Event Type  malfunction  

Manufacturer Narrative

The investigation is still ongoing for this event.When the investigation is completed a follow-up will be sent to the fda.

Event Description

It has been reported to philips that the table moved in cradle position during a cardiac procedure without being requested by the user.No harm to the patient or user was reported.Philips has started an investigation of this complaint.

Manufacturer Narrative

Philips has investigated this complaint.The reported problem occurred twice on (b)(6) 2020 during two different patient procedures.This report is about the first patient.According to the information collected, when the table cradled without a user request, the customer rebooted the system and pressed the reset geo(metry) button which turned back the table to zero-position.The cardiac procedure was completed successfully after a short delay.A philips engineer inspected the system onsite and could not reproduce the reported problem.Analysis of the log files showed that the table cradled without a user request, however the cause of this could not be identified.The amc ecat drive, niu and geometry module were replaced proactively.In (b)(6) 2020, the issue reoccurred during system start up.A philips engineer went onsite and could not reproduce the reported problem.Philips disabled the cradle movement to prevent reoccurrence of the issue.To further investigate, philips requested the table cradle parts back for analysis.The customer declined this request and confirmed that they are satisfied with the cradle function being disabled.No further investigation is possible.No similar complaints have been reported to philips (outside this customer site).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 FD20
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; p.o. box 10.000; best 5680 DA; NL 5680 DA
• MDR Report Key: 10406144
• MDR Text Key: 203523721
• Report Number: 3003768277-2020-00050
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838054202
• UDI-Public: (01)00884838054202
• Combination Product (y/n): N
• PMA/PMN Number: K141979
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 722028
• Device Catalogue Number: 722028
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 84