MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD10; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number ALLURA XPER FD10

Device Problem Unintended System Motion (1430)

Patient Problem Pain (1994)

Event Date 06/10/2022

Event Type  Injury  

Event Description

It has been reported to philips that while transferring the patient from the table to the stretcher, the table unexpectedly pivoted.The patient is approximately 100kg and has no legs.Three staff members prevented him from falling and were injured.This report concerns a radiology tech who injured their back.This was treated with valium and analgesics.It has been reported that the pain persists and the tech has not yet returned to work due to the injury.No harm has been reported on the patient.Based on information provided, the pain experienced by the technologist is significant enough to prevent them from working, therefore is being reported conservatively as a serious injury.Philips has started an investigation of this complaint.

Manufacturer Narrative

Philips has investigated the reported problem.A philips service engineer inspected the system on site and identified a deposit of contrast product on the table pivot which resulted in less resistance when in a specific pivot stop position.The deposit was removed, and the system was returned to use in good working order.Corrected data: coding updated based on investigation outcome.

• Brand Name: ALLURA XPER FD10
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 14751659
• MDR Text Key: 294383134
• Report Number: 3003768277-2022-00291
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K041949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ALLURA XPER FD10
• Device Catalogue Number: 722003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/10/2022
• Initial Date FDA Received: 06/21/2022
• Supplement Dates Manufacturer Received: 06/10/2022
• Supplement Dates FDA Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2007
• 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
• Patient Outcome(s): Other
• Patient Age: 33 YR