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

Model Number ALLURA XPER FD10

Device Problems No Display/Image (1183); No Apparent Adverse Event (3189)

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

Event Date 12/07/2023

Event Type  malfunction  

Event Description

It has been reported to philips that the customer received an error message and the system turned off.No harm has been reported to philips.Philips has started an investigation of this complaint.

Manufacturer Narrative

Philips has investigated this complaint.This complaint was received on the allura system and alleged that the system turned off.At the time the complaint was received, philips did not have enough information to assess the impact of this issue on the live x-ray imaging functionality of the system and on the clinical procedure.Since at the time it was not possible to determine whether the issue would likely cause or contribute to death or serious injury upon recurrence, the complaint was conservatively reported.After investigation, philips has identified that the issue did not occur on the allura system but on the xper flex cardio monitoring equipment.The complaint did not contain any allegation or indication that the reported malfunction was or could be difficult to detect, since the device reportedly shut down during use.In the event of an unexpected shut down the system will display a "monitoring off" error message on the monitoring screen.A trained clinical professional would act accordingly to manually assess the patient and utilize alternate monitoring equipment (if required) which is specified / recommended in our labeling) before initiating treatment.This device/product issue did not cause or contribute to death or serious injury nor would likely cause or contribute to death or serious injury upon recurrence.After re-evaluation, as per non-reportable rationale device - hemo ¿ 12, philips concludes that this complaint is not reportable.The device problem code and evaluation method code were corrected.Codes were updated based on investigation outcome.

• Brand Name: ALLURA XPER FD
• 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: derrick massuri ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 18354439
• MDR Text Key: 330870559
• Report Number: 3003768277-2023-07045
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838054189
• UDI-Public: 00884838054189
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K161563
• 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: 12/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ALLURA XPER FD10
• Device Catalogue Number: 722026
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2016
• 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