MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA FC; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Model Number ALLURA FC

Device Problems No Display/Image (1183); Radiation Output Failure (4027)

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

Event Date 09/29/2022

Event Type  malfunction  

Event Description

It was reported to philips that the customer was unable to view images on the live monitor of the allura fc device.It is unknown if the device was in use at the time of the event as this information was not provided.No patient harm or injury was reported.A investigation has been opened to evaluate this event.

Manufacturer Narrative

Philips has investigated this complaint.According to the additional information collected, the system was outside of clinical use when the issue occurred.The philips remote service engineer (rse) analyzed the system remotely and confirmed that the issue in viewing images in the live monitor.The rse determined that the mcs monitor source settings got changed.The rse assisted the customer to change the mcs setting to vdi.After reset of mcs monitor settings to vdi, the system was returned to use in good working order.Based on service history review, the issue did not reoccur.The codes were updated based on the investigation outcome.Device problem code was corrected.

• Brand Name: ALLURA FC
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15695110
• MDR Text Key: 304702184
• Report Number: 3010685285-2022-00003
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K022899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: ALLURA FC
• Device Catalogue Number: 723003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2022
• Initial Date FDA Received: 10/29/2022
• Supplement Dates Manufacturer Received: 12/05/2022
• Supplement Dates FDA Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1