MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD10; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 722003

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

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

Event Type  malfunction  

Manufacturer Narrative

The investigation is still ongoing on this event.When the investigation is completed, a follow-up will sent to the fda.(b)(4).

Event Description

Philips received a complaint from the customer in which they stated that on (b)(6) 2016 during clinical operation, the nurse moved the radiation shield suspension.The ceiling mounted mavig arm where the shield hung upon, broke off at the joint and fell.The nurse helped break the fall of the radiation shield and no one was hurt but the nurse is very sore from taking this added weight and inertia of the shield.No other harm due to this event, was reported.The welds did not fail.The horizontal extension arm metal fatigued and failed.

Manufacturer Narrative

According to an investigation from philips and the supplier, the suspension most likely broke due to its age (12 years) and several impacts of mechanical overload inducing cracks.Risk analysis by the supplier shows a failure rate of (b)(4) for this product and this failure mode.Based on this information it was decided not to take further actions at the moment.However, philips and the supplier will discuss what to do when the arm is older than the expected life cycle of ten years.The expected life cycle is described in the instructions for use of the mavig portegra2 arm.(b)(4).

• Brand Name: ALLURA XPER FD10
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• 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: 5549927
• MDR Text Key: 42537970
• Report Number: 3003768277-2016-00034
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K041949
• 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: 03/11/2016

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: 722003
• Device Catalogue Number: 722003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/11/2016
• Initial Date FDA Received: 04/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2005
• 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