MAUDE Adverse Event Report: PHILIPS HEALTHCARE PHILIPS MULTIDIAGNOST ELEVA; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 708032

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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 they were trying to setup and use the room, but the c-arm of the md eleva was free floating.A field service engineer of philips noticed that it was possible by pulling the c-arm from its transverse carriage bearings, it could possibly fall and harm patients or bystanders.No patient or bystander was harmed due to this issue.

Manufacturer Narrative

Philips investigated this complaint and came to the following conclusion: failure mode not recognized in fmea resulting in a design which is not single fault safe.Failure mode not recognized in fmea resulting in a design that did not use a safety factor.Assembly torque of the bolts is too high, causing pre torque loss of the bolts after aluminum plastic deformation.No finite element method (fem) analysis was performed during design resulting in plastic deformation/relaxation of the aluminum block with subsequently pre torque loss of the bolts.Design was unknown with the contributing factors of hydrogen embrittlement.Philips has initiated a field safety corrective action for this problem.

• Brand Name: PHILIPS MULTIDIAGNOST ELEVA
• 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: 5708631
• MDR Text Key: 48095107
• Report Number: 3003768277-2016-00058
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/27/2016

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: 708032
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/27/2016
• Initial Date FDA Received: 06/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2004
• 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