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

Model Number 722010

Device Problem Device Fell (4014)

Patient Problem Laceration(s) (1946)

Event Type  malfunction  

Manufacturer Narrative

When the investigation has been completed philips will inform the fda.

Event Description

It has been reported to philips that the flexvision monitor fell from the support frame just before an electrophysiology procedure was to begin.A nurse received a cut on her finger, which did not require stitches.A patient was on the table but was not injured.Philips has started an investigation for this complaint.

Manufacturer Narrative

Philips has investigated this complaint.Philips has confirmed that no patient harm occurred.The patient was in the room, but the procedure was not started yet.Once the incident occurred, the procedure was rescheduled for another day.The user was treated for the cut and was able to resume work.The log files of the system have been analyzed and the log files show that the or table¿s force sensor registered a high force collision and downward movement.The table force sensor continued to register high force until it was pushed to its limits after which the table force sensor failed.Philips has inspected the system on site and checked the customer set-up of the monitor and the or table.The set-up includes a vertical pole attached to the or table, that comes in contact with the monitor when the monitor is moved downwards, leading to a collision.Based on the analysis of the logfiles and the onsite inspection of the system and the set-up, philips concludes that the following sequence of events occurred: while preparing the system for use, the operator lowered the flexvision monitor via the monitor ceiling suspension.The monitor was lowered to a point where it came in contact with a vertical pole attached to the or table.This led to a high force collision between the monitor and the table (via the pole) which forced the monitor out of the release bracket and supports.The instructions for use (4522 203 17232) describe that the user should take care when moving the monitor ceiling suspension (mcs) and to prevent collisions and injury.The flexvision monitor, actuator and monitor frame were replaced, the or table was checked and the system was returned to use in good working condition.No similar complaints were found.Consequently, philips has closed this complaint.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 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
• MDR Report Key: 9382687
• MDR Text Key: 181522271
• Report Number: 3003768277-2019-00097
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• PMA/PMN Number: K041949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/04/2019

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: 722010
• Device Catalogue Number: 722010
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/04/2019
• Initial Date FDA Received: 11/27/2019
• Supplement Dates Manufacturer Received: 11/04/2019
• Supplement Dates FDA Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1