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

Model Number 722012

Device Problems Break (1069); Component Falling (1105); Unintended Collision (1429)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Analysing the images with our subject matter expert we concluded that a lateral collision occurred.The screw that holds the bar was snapped.When the investigation has been completed, philips will inform the fda.(b)(4).

Event Description

Philips received a complaint from the customer in which they stated that the bar between the c-arm and monitor fell down due a collision.The screw that holds the bar was snapped.No patient or user was harmed due to this issue.

Manufacturer Narrative

The results of the investigation are as follows: the customer reported that on (b)(6) 2016, the bar between the c-arm and monitor fell down due to a lateral collision.The screw holding the bar snapped.Nobody was injured due to this event.Investigation by a philips a subject matter expert identified that the bar was locally installed in a position that is not part of the design so it would push the monitor ceiling suspension (mcs) away when the stand is moved longitudinally.The bar was installed outside the patient area to act as a stop bar to prevent the carriage to collide with the monitor ceiling carriage (mcc).However, the bar got a lateral force from the lead screen holder when the stand was moved lateral.This caused the bar to break and fall down.The bar has not been reinstalled.Philips has triggered the capa process and with this action we consider this case closed.

• 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
• 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: 5959777
• MDR Text Key: 55380012
• Report Number: 3003768277-2016-00086
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K033737
• 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: 08/30/2016

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: 722012
• Device Catalogue Number: 722012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/30/2016
• Initial Date FDA Received: 09/19/2016
• Supplement Dates Manufacturer Received: 08/30/2016
• Supplement Dates FDA Received: 07/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2012
• 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