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

Model Number ALLURA XPER FD20

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2020

Event Type  malfunction  

Event Description

It has been reported to philips that during a procedure oil leaked from the c-arm.The procedure was aborted and the patient moved to another room.No harm to the patient and user has been reported to philips.Philips has started an investigation of this complaint.

Manufacturer Narrative

A philips engineer inspected the system onsite and identified that there was a small hole in the (x-ray tube) cooling hose causing the oil leak.The philips engineer replaced the cooling hose and the system was returned to use in good working order.

• Brand Name: ALLURA XPER FD
• Type of Device: ANGIOGRAPHIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• MDR Report Key: 11162485
• MDR Text Key: 226543350
• Report Number: 3003768277-2021-00007
• Device Sequence Number: 1
• Product Code: IZI
• UDI-Device Identifier: 00884838059054
• UDI-Public: 00884838059054
• Combination Product (y/n): N
• PMA/PMN Number: K130842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup

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: ALLURA XPER FD20
• Device Catalogue Number: 722012
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 12/15/2020
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 12/15/2020
• Supplement Dates FDA Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 2 YR
• Patient Weight: 8