MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD10/10; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number ALLURA XPER FD10/10

Device Problem No Display/Image (1183)

Patient Problems Myocardial Infarction (1969); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/06/2023

Event Type  malfunction  

Event Description

It has been reported to philips that the live monitor was not working.The system was in clinical use for an emergency procedure on a patient with st elevation myocardial infarction when this occurred.The patient procedure had not started, but the patient was already on the table and prepared for the examination.The patient was then moved to another system for the procedure during which time the patient's condition worsened and they were connected to a heart-lung machine.Philips has started an investigation of this complaint.

Manufacturer Narrative

Philips has investigated this complaint.According to the information collected, the system was in clinical use when the issue occurred.The philips field service engineer (fse) inspected the system onsite and confirmed that there was a malfunction in the live monitor display which didn't work and turned dark after switching it on.The fse identified that the issue occurred due to the defective monochrome monitor.The fse replaced the monitor.After the replacement, the system was returned to use in good working order.The codes were updated based on the investigation outcome.Patient outcome code and health impact code were corrected.

• Brand Name: ALLURA XPER FD10/10
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• 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: 16565964
• MDR Text Key: 311508763
• Report Number: 3003768277-2023-01753
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K031333
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ALLURA XPER FD10/10
• Device Catalogue Number: 722005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/06/2023
• Initial Date FDA Received: 03/17/2023
• Supplement Dates Manufacturer Received: 09/27/2023
• Supplement Dates FDA Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2005
• 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