MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD20; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 722012

Device Problem Defective Component (2292)

Patient Problem Death (1802)

Event Date 01/11/2019

Event Type  malfunction  

Manufacturer Narrative

When the investigation is completed a follow-up report will be sent to the fda.

Event Description

Philips has received through the (b)(6) agency an adverse incident report submitted by the (b)(6) hospital (b)(4).In this report it was reported: table fault during case.Soft restart then full restart carried out.Fault cleared.Log file sent to phillips and reported.(b)(4).Delay of approx.30 mins to case.New part and fitting date booked.Room can carry on being used.The adverse incident report indicated as type of injury ¿death¿.In the section details of injury it was indicated ¿none ¿ delayed procedure by 30 minutes¿.Philips has initiated an investigation of this complaint.

Manufacturer Narrative

Philips investigated the complaint.Philips checked the system on site and confirmed that the tilt potential meter was not operating correctly.The tilt potential meter was replaced on january 29th after which the system was returned to use in good working order.An analysis of the log files confirmed a failure of the tilt potential meter.Because the tilt potential meter was not operating correctly, the system intermittently identifies that the table is in a tilted position while the table is in horizontal position.In case a table is tilted, free floating longitudinal table movements are no longer possible.This is an expected behavior of the system.Whenever the table is tilted, the longitudinal table movement is only motorized to prevent the patient from falling from the table in case the pan handle is pressed.Based on trending analysis there is no exceptional replacement rate for the tilt potential meter.No further actions will be taken.Initially this report was classified as death, but after further investigation philips has been informed that the patient did not pass away, therefor the classification is changed to malfunction.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: ALLURA XPER FD20
• 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
• MDR Report Key: 8373828
• MDR Text Key: 137260473
• Report Number: 3003768277-2019-00015
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K033737
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 722012
• Device Catalogue Number: 722012
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 67 YR
• Patient Weight: 122