MAUDE Adverse Event Report: PHILIPS USA PHILLIPS BV PULSERA - C -ARM IMAGING SYSTEM; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Insufficient Information (4580)

Event Date 01/28/2016

Event Type  malfunction  

Event Description

A medtronic representative reported that they were unable to activate the lateral image during a 2d c-arm case.They were able to acquire a good empty image and ap without issue.They tried 11 times to acquire the lateral, adjusting the kv every time, but received an 'image activation failed' message every time.They aborted navigation but were able to continue with the surgery.They are using a phillips bv pulsera with spine 2.0.1.Navigation was discontinued after incision.A medtronic field service engineer confirmed that the c- a rm had a generator issue and was out of service.It was confirmed the phillips bv pulsera c-arm caused the issue and not the navigation system.(b)(4) this report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PHILLIPS BV PULSERA - C -ARM IMAGING SYSTEM
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): PHILIPS USA
• MDR Report Key: 17525593
• MDR Text Key: 321357045
• Report Number: MW5132534
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2016

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1