MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number ALLURA XPER FD20

Device Problem Unstable (1667)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/12/2023

Event Type  malfunction  

Event Description

It was reported to philips that the table pivot break would not apply and therefore the table pivot was free to move.The device was inside of clinical use at the time of the event.No harm was reported to philips.Philips has started an investigation for this complaint.

Manufacturer Narrative

Philips has investigated this complaint.According to the additional information provided, the procedure was planned treatment /non-emergency treatment, but it was delayed and it got completed as planned.Upon investigation, fse confirmed that the issue was with pivot brake assy.The philips engineer brake unit inside the top plate, and increased the compression strength.The system was returned to use in good working order.At the time this complaint was received, philips did not have enough information to exclude the potential for death or serious injury on recurrence, and as such the complaint was reported.Since that time, new information has been received which has led to the determination that this is scenario is not likely to cause or contribute to death or serious injury if it were to recur.The pivot movements of the tabletop are needed to image the arm for dialysis access or procedures using radial or brachial access.The pivot function is unlocked by the control module and physically pushed in the desired direction.If the table cannot be manually pivoted, the region of interest can be centered by rotating the stand and panning the table sideward.Additionally, the table brakes are released when the geometry stop button is pressed, therefore loss of manual pivot movements is not likely to cause or contribute to death or a serious injury.Based on the investigation results, philips concluded that the complaint is not reportable.The codes were updated based on the investigation outcome.

• Brand Name: ALLURA XPER FD20
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16770742
• MDR Text Key: 313597747
• Report Number: 3003768277-2023-02427
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K033737
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ALLURA XPER FD20
• Device Catalogue Number: 722006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2009
• 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