MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD10/10 OR TABLE; ANGIOGRAPHIC X-RAY SYSTEM, SOLID X-RAY IMAGER

Model Number 722019

Device Problem Unintended Movement (3026)

Patient Problem Injury (2348)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported to philips that after a procedure was finished, a blanket was thrown over the geometry table side operation module.This resulted in the c-arm movement button being accidentally pressed and the c-arm moving to the left anterior oblique position.When the c-arm moved, a nurse was pinned down between the anesthesia cart and the c-arm.She was injured on one leg and required medical attention.To date philips has not received information about the severity of the injury.

Manufacturer Narrative

Philips investigated this complaint.The system was checked on site and no malfunction was found.Philips has completed a good faith effort to get information on the severity of the injury with no positive results.No further actions will be taken by philips.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 FD10/10 OR TABLE
• Type of Device: ANGIOGRAPHIC X-RAY SYSTEM, SOLID X-RAY IMAGER
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; p.o. box 10.000; best 5680 DA; NL 5680 DA
• MDR Report Key: 8361266
• MDR Text Key: 137278390
• Report Number: 3003768277-2019-00012
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• PMA/PMN Number: K102005
• 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: 12/06/2018

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: 722019
• Device Catalogue Number: 722019
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 02/22/2019
• Supplement Dates Manufacturer Received: 12/06/2018
• Supplement Dates FDA Received: 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1