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

Model Number ALLURA FC

Device Problem Radiation Output Failure (4027)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2022

Event Type  malfunction  

Event Description

It was reported to philips that the exposure was not possible on the cardio vascular system-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 patent injury or harm was alleged.An investigation has been opened to evaluate this event.

Manufacturer Narrative

Philips has investigated this complaint.The philips field service engineer (fse) inspected the system onsite and confirmed that the system¿s ¿exposure was not possible properly¿ upon investigation, fse noticed the error¿s displayed on the system.As fse tried replacing ccb board, still the issue persists.As fse replaced frame rate board to solve the issue.After replacing generator touch screen console, to resolve touch sense issue, the system was returned to use in good working order, with required calibration done.The codes were updated based on the investigation outcome.

• 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: 15704314
• MDR Text Key: 304702235
• Report Number: 3010685285-2022-00004
• 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: 10/01/2022
• Initial Date FDA Received: 10/31/2022
• Supplement Dates Manufacturer Received: 09/04/2023
• Supplement Dates FDA Received: 09/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1