MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA FC; INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM

Model Number ALLURA FC

Device Problem Unexpected Shutdown (4019)

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

Event Date 10/19/2022

Event Type  malfunction  

Event Description

It has been reported to philips that the generator switch of automatically.There was no reported patient or user harm.

Manufacturer Narrative

Philips has investigated this complaint.According to the additional information collected the customer was performing a diagnostic coronary procedure for the patient and the procedure was completed with a delay (<20 minutes).The philips field service engineer (fse) inspected the system onsite and identified that generator switching off automatically during the procedure.The actual cause of the reported problem was determined to be a faulty safety supervisor board.Fse reseated the mpu and safety supervisor board (ssb) cables, then replaced safety supervisor board.After replacing the safety supervisor board the system was returned to use in good working order.The codes were updated based on the investigation outcome.

• Brand Name: ALLURA FC
• Type of Device: INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
• 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: 15804397
• MDR Text Key: 303822886
• Report Number: 3010685285-2022-00005
• 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,Distributor
• 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: 10/19/2022
• Initial Date FDA Received: 11/16/2022
• Supplement Dates Manufacturer Received: 12/01/2022
• Supplement Dates FDA Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2013
• 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