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

Model Number 722018

Device Problems Contamination (1120); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 03/07/2017

Event Type  malfunction  

Event Description

Philips received a complaint from the customer in which it was stated that during a procedure where a pacemaker and a mechanical valve needed to be placed in the patient, the c-arm started moving without any command from the user.C-arm hit the patient and contaminated the sterile field.Furthermore the c-arc did not move anymore and did not respond on any commands, than the doctor decided to completely stop the system and the procedure was aborted.The patient needed to be sutured and will be called back in order to finish the procedure within 15 days.

Manufacturer Narrative

Philips investigated this complaint and came to the following conclusion: on (b)(6) 2017, the field service engineer (fse), found that the tso (table side operation) was defective and replaced it.After replacing the tso, the system was working according to specification and was returned to the customer for use.A log file analysis, done on (b)(6) 2017 by our senior service specialist, shows that the system detected a soft collision.The system was rebooted by the user.After the reboot, tso (table side operation) commands were still active.Most likely, the accidental movement was activated by the customer/protection sheet or due to a defective tso module.Conclusion of the analysis: the c-arc made a spontaneous movement due to a defective tso module.This event was changed from serious injury to a non adverse event as a sepsis test that was taken did not show an infection.The patient was rescheduled and came back to the hospital for the procedure on (b)(6)2017.The procedure was performed successfully.

• Brand Name: INTEGRIS ALLURA 9
• 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: 6403654
• MDR Text Key: 69900412
• Report Number: 3003768277-2017-00030
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K002016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 722018
• Device Catalogue Number: 722018
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/07/2017
• Initial Date FDA Received: 03/14/2017
• Supplement Dates Manufacturer Received: 03/07/2017
• Supplement Dates FDA Received: 08/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2007
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 81 YR
• Patient Weight: 80