MAUDE Adverse Event Report: PHILIPS HEALTHCARE INTEGRIS ALLURA 9 BIPLANE; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 722021

Device Problem Loss of Power (1475)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

When the investigation has been completed philips will inform the fda.

Event Description

It has been reported to philips that during a procedure on a newborn patient the system spontaneously stopped working.The patient was transferred to another room where the procedure was completed.To date philips has not received further information about the condition of the patient.An investigation of the reported issue has been initiated.

Manufacturer Narrative

Philips investigated this complaint.No information on the condition of the patient has been provided to philips.The system was checked on site and no issue was found.The analysis of the log files did not show any issue that could explain the reported issue.It was considered that the reported problem could be related to the main power line connected to the system.The power line was monitored during 2 months and no problem was identified during this period.Based on the investigation performed, philips has not been able to determine the cause of the reported issue.

• Brand Name: INTEGRIS ALLURA 9 BIPLANE
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; p.o. box 10.000; best 5680 DA; NL 5680 DA
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: dusty leppert ; veenpluis 4-6; p.o. box 10.000; best 5680 -DA ; NL 5680 DA
• MDR Report Key: 7905449
• MDR Text Key: 121718774
• Report Number: 3003768277-2018-00073
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K002016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 722021
• Device Catalogue Number: 722021
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2003
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 1 MO
• Patient Weight: 4